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Bacitracin Zinc Antibiotic Ointment · Ointment
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Decreased Cell Wall Synthesis & Repair [PE] | PE | All 41 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 000004-004 | PAREDRINE | SOLUTION/DROPS | HYDROXYAMPHETAMINE HYDROBROMIDE | Discontinued | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 11 | Labeling | Approved | May 26, 1987 | — |
| Supplement | 10 | Labeling | Approved | May 8, 1980 | — |
| Original application | 1 | Approved | July 16, 1969 | Unknown |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251008). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses temporarily relieves cough due to minor throat and bronchial irritation associated with a cold temporarily relieves minor aches and pains of muscles and joints
Purpose
openFDA Drug LabelingPurpose Cough suppressant & topical analgesic
Dosage and Administration
openFDA Drug LabelingDirections See important warnings under "When using this product" • adults and children 2 years and over: > Rub a thick layer on the throat and chest for cough, or rub on sore aching muscles or joints > Clothing should be left loose about the throat and chest to help vapors reach the nose and mouth > Use up to 3 times daily or as directed by doctor Cover with a warm, dry cloth if desired • children under 2 years: do not use
Warnings
openFDA Drug LabelingWarnings For external use only; avoid contact with eyes. Do not use by mouth in nostrils on wounds or damaged skin with tight bandages 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 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. Stop use and ask a doctor if muscle aches and pains worsen or persist for more 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
openFDA Drug LabelingDO NOT USE if you are allergic to any of the ingredients in the eyes over large areas of the body
Ask a Doctor
openFDA Drug LabelingAsk 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
Stop Use
openFDA Drug LabelingStop use and ask a doctor if muscle aches and pains worsen or persist for more 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.
Active Ingredient
openFDA Drug LabelingActive ingredients Camphor (synthetic) 4.8% .....................................................Cough suppressant & topical analgesic Eucalyptus Oil 1.2% .............................................................. Cough suppressant Menthol 2.6% .........................................................................Cough suppressant & topical analgesic
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: MENTHOL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 79903-194-17 | 79903-194 | Walmart Inc | 1 JAR in 1 CARTON (79903-194-17) / 50 g in 1 JAR | August 1, 2023 |
| 79903-372-01 | 79903-372 | Walmart Inc. | 1 TUBE in 1 CARTON (79903-372-01) / 28 g in 1 TUBE | January 27, 2025 |
| 79903-194 | 79903-194 | Walmart Inc | — | August 1, 2023 |
| 79903-372 | 79903-372 | Walmart Inc. | — | January 27, 2025 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.