Vicks VapoRub — v9

Vicks VapoRub

11 Views

Version

v9

Effective date

October 1, 2025

Original packager

Yes

Sections captured

18

Identifiers

Document ID
401d8195-9510-cf8b-e063-6394a90a048f
Set ID
699879f9-4a7e-3680-e053-2a91aa0a44af
Application numbers
M012
Product NDCs
58933-671
Package NDCs
58933-671-01
Original packager NDCs
—

Names & Manufacturers

Brand names
Vicks VapoRub
Generic names
CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL
Manufacturer names
Procter & Gamble Manufactura S de RL de CV
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, MENTHOL
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
200293
UNII
2R04ONI662, 5TJD82A1ET, L7T10EIP3A
UPC
0323900010512

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredients Camphor (synthetic) 4.7% Eucalyptus oil 1.2% Menthol 2.6% Purpose Cough suppressant & topical analgesic Cough suppressant Cough suppressant & topical analgesic
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma or emphysema
Do Not Use (1)

Sequence 1

Do not use by mouth in nostrils on wounds or damaged skin with tight bandages
Dosage And Administration (1)

Sequence 1

Directions see important warnings under "When using this product" adults and children 2 years and over: for cough suppression rub a thick layer on throat & chest cover with a warm, dry cloth if desired keep clothing loose about throat and chest to help vapors reach the nose and mouth use up to three times daily or as directed by doctor for muscle / joint minor aches and pains apply to affected area not more than 3 to 4 times daily children under 2 years: do not use
Inactive Ingredient (1)

Sequence 1

Inactive ingredients cedarleaf oil, fragrance, nutmed oil, petrolatum, thymol. turpentine oil
Indications And Usage (1)

Sequence 1

Uses when applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold when applied to muscles and joints, temporarily relieves minor aches and pains of muscles and joints
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children.
Overdosage (1)

Sequence 1

If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton Vicks ® VapoRub COUGH SUPPRESSANT TOPICAL ANALGESIC Ointment Lemon Scent NET WT 1.76 OZ (50 g) 671
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Cough suppressant & topical analgesic Cough suppressant Cough suppressant & topical analgesic
Questions (1)

Sequence 1

Questions? 1-800-873-8276
Spl Product Data Elements (1)

Sequence 1

Vicks VapoRub Camphor (synthetic), Eucalyptus oil, and Menthol PETROLATUM CEDAR LEAF OIL NUTMEG OIL THYMOL TURPENTINE OIL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) EUCALYPTUS OIL EUCALYPTUS OIL MENTHOL MENTHOL
Spl Unclassified Section (4)

Sequence 1

Drug Facts

Sequence 2

Only selected information is listed on the jar label. Keep carton for future reference.

Sequence 3

TAMPER EVIDENT: Carton sealed for your protection.

Sequence 4

MADE IN MEXICO DIST. BY PROCTER & GAMBLE, CINCINNATI, OH 45202
Stop Use (1)

Sequence 1

Stop use and ask a doctor if muscle aches and pains worsen or persist for mor than 7 days or clear up and occur again within a few days. cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Storage And Handling (1)

Sequence 1

Other information store at room temperature
Warnings (1)

Sequence 1

Warnings For external use only; avoid contact with eyes.
When Using (1)

Sequence 1

When using this product, do not heat microwave add to hot water or any container where heating water. May cause splattering and result in burns.

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['Vicks VapoRub'],
 'generic_name': ['CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL'],
 'is_original_packager': [True],
 'manufacturer_name': ['Procter & Gamble Manufactura S de RL de CV'],
 'package_ndc': ['58933-671-01'],
 'product_ndc': ['58933-671'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['200293'],
 'spl_id': ['401d8195-9510-cf8b-e063-6394a90a048f'],
 'spl_set_id': ['699879f9-4a7e-3680-e053-2a91aa0a44af'],
 'substance_name': ['CAMPHOR (SYNTHETIC)', 'EUCALYPTUS OIL', 'MENTHOL'],
 'unii': ['5TJD82A1ET', '2R04ONI662', 'L7T10EIP3A'],
 'upc': ['0323900010512']}