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Bacitracin
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Bacitracin | 500 U/g | 1648110 | View |
| Bacitracin | 500 [USP'U]/1000mg | 1648110 | View |
| Bacitracin | 500 [USP'U]/g | 1648110 | View |
| Bacitracin | 500 [iU]/g | 1648110 | View |
| Bacitracin Zinc | 500 [USP'U]/g | 204602 | View |
| Bacitracin Zinc | 500 [iU]/g | 204602 | View |
Forms, 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 20251201). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingDIRECTION Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.
Purpose
openFDA Drug LabelingActive Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic
Dosage and Administration
openFDA Drug Labelingdosage and administration Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for 2 weeks If condition persists longer, consult a doctor This product is not effective on the scalp or nails
Warnings
openFDA Drug LabelingWarnings: For external use only Dosage and Administration: • clean the affected areas • apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily • may be covered with a sterile bandage Stop use and ask a doctor if • the condition persists or gets worse, or if a rash or other allergic reaction develops. Do not use: • if you are allergic to any of the ingredients • in the eyes • over large areas of the body • longer than 1 week unless directed by a doctor 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 Do not use In the eyes or over large areas of the body If you are allergic to any of the ingredients Longer than 1 week unless directed by a doctor.
DO NOT USE Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops.
Ask a Doctor
openFDA Drug LabelingASK A DOCTOR Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops
Active Ingredient
openFDA Drug LabelingACTIVE INGRIDIENT Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Bacitracin First Aid Antibiotic Ointment NDC 72162-2280-2: 144 Unit dose Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: BACITRACIN. 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 |
|---|---|---|---|---|
| 50090-0815-0 | 50090-0815 | A-S Medication Solutions | 1 TUBE in 1 CARTON (50090-0815-0) / 14 g in 1 TUBE | November 28, 2014 |
| 50090-0845-0 | 50090-0845 | A-S Medication Solutions | 144 PACKET in 1 CARTON (50090-0845-0) / .9 g in 1 PACKET | November 28, 2014 |
| 84387-002-01 | 84387-002 | ALLIED TRADE LINK LLC | 28.4 g in 1 TUBE (84387-002-01) | October 24, 2024 |
| 87236-000-01 | 87236-000 | AlderMed Inc. | 1 TUBE in 1 CARTON (87236-000-01) / 28.4 g in 1 TUBE | November 1, 2025 |
| 87236-000-02 | 87236-000 | AlderMed Inc. | .9 g in 1 PACKET (87236-000-02) | November 1, 2025 |
| 87236-000-14 | 87236-000 | AlderMed Inc. | 1 TUBE in 1 CARTON (87236-000-14) / 14.2 g in 1 TUBE | November 1, 2025 |
| 87236-000-44 | 87236-000 | AlderMed Inc. | 144 PACKET in 1 CARTON (87236-000-44) / .9 g in 1 PACKET | November 1, 2025 |
| 68001-477-46 | 68001-477 | BluePoint Laboratories | 1 TUBE in 1 CARTON (68001-477-46) / 14.2 g in 1 TUBE | November 24, 2020 |
| 68001-477-47 | 68001-477 | BluePoint Laboratories | 1 TUBE in 1 CARTON (68001-477-47) / 28.4 g in 1 TUBE | November 24, 2020 |
| 68001-477-48 | 68001-477 | BluePoint Laboratories | 1 PACKET in 1 CARTON (68001-477-48) / .9 g in 1 PACKET (68001-477-45) | November 24, 2020 |
| 71335-2731-1 | 71335-2731 | Bryant Ranch Prepack | 144 PACKET in 1 CARTON (71335-2731-1) / .9 g in 1 PACKET | July 30, 2025 |
| 72162-2280-2 | 72162-2280 | Bryant Ranch Prepack | 144 PACKET in 1 CARTON (72162-2280-2) / .9 g in 1 PACKET | September 6, 2024 |
| 59779-536-64 | 59779-536 | CVS Pharmacy | 1 TUBE in 1 CARTON (59779-536-64) / 28 g in 1 TUBE | June 8, 2005 |
| 0713-0280-31 | 0713-0280 | Cosette Pharmaceuticals, Inc. | 28.4 g in 1 TUBE (0713-0280-31) | January 10, 1995 |
| 67777-116-10 | 67777-116 | Dynarex Corporation | 1728 BOX in 1 CASE (67777-116-10) / 144 PACKET in 1 BOX (67777-116-11) / 900 mg in 1 PACKET | September 12, 2016 |
| 67777-116-20 | 67777-116 | Dynarex Corporation | 72 TUBE in 1 CASE (67777-116-20) / 14000 mg in 1 TUBE (67777-116-21) | September 12, 2016 |
| 67777-116-30 | 67777-116 | Dynarex Corporation | 72 BOX in 1 CASE (67777-116-30) / 1 TUBE in 1 BOX (67777-116-31) / 28400 mg in 1 TUBE | September 12, 2016 |
| 37808-536-64 | 37808-536 | H E B | 1 TUBE in 1 CARTON (37808-536-64) / 28 g in 1 TUBE | June 15, 1991 |
| 41226-880-02 | 41226-880 | Kroger | 1 TUBE in 1 CARTON (41226-880-02) / 28 g in 1 TUBE | November 15, 2025 |
| 30142-536-64 | 30142-536 | Kroger Company | 1 TUBE in 1 CARTON (30142-536-64) / 28 g in 1 TUBE | April 19, 2017 |
| 41250-844-64 | 41250-844 | Meijer Distribution Inc | 1 TUBE in 1 CARTON (41250-844-64) / 28 g in 1 TUBE | October 24, 2018 |
| 68071-5253-3 | 68071-5253 | NuCare Pharmaceuticals,Inc. | 28.4 g in 1 BOX (68071-5253-3) | May 8, 2020 |
| 45802-060-01 | 45802-060 | Padagis Israel Pharmaceuticals Ltd | 1 TUBE in 1 CARTON (45802-060-01) / 14 g in 1 TUBE | September 1, 2011 |
| 45802-060-03 | 45802-060 | Padagis Israel Pharmaceuticals Ltd | 1 TUBE in 1 CARTON (45802-060-03) / 28 g in 1 TUBE | August 5, 2011 |
| 45802-060-70 | 45802-060 | Padagis Israel Pharmaceuticals Ltd | 144 PACKET in 1 CARTON (45802-060-70) / .9 g in 1 PACKET | June 20, 2011 |
| 68788-4153-2 | 68788-4153 | Preferred Pharmaceuticals Inc. | 1 TUBE in 1 BOX (68788-4153-2) / 28 g in 1 TUBE | July 15, 2026 |
| 68788-8643-2 | 68788-8643 | Preferred Pharmaceuticals Inc. | 28.4 g in 1 TUBE (68788-8643-2) | April 30, 2024 |
| 68788-9794-2 | 68788-9794 | Preferred Pharmaceuticals, Inc | 28 g in 1 TUBE (68788-9794-2) | April 30, 2012 |
| 63187-299-01 | 63187-299 | Proficient Rx LP | 28.35 g in 1 TUBE (63187-299-01) | January 1, 2019 |
| 71205-057-01 | 71205-057 | Proficient Rx LP | 28.4 g in 1 TUBE (71205-057-01) | June 1, 2018 |
| 0536-1256-28 | 0536-1256 | RUGBY LABORATORIES | 30 g in 1 BOX (0536-1256-28) | April 30, 2020 |
| 69396-027-01 | 69396-027 | Trifecta Pharmaceuticals USA, LLC. | 1 TUBE in 1 BOX (69396-027-01) / 28 g in 1 TUBE | March 15, 2017 |
| 69396-027-33 | 69396-027 | Trifecta Pharmaceuticals USA, LLC. | 3 TUBE in 1 BOX (69396-027-33) / 28 g in 1 TUBE | May 15, 2025 |
| 69396-027-44 | 69396-027 | Trifecta Pharmaceuticals USA, LLC. | 4 TUBE in 1 BOX (69396-027-44) / 28 g in 1 TUBE | March 15, 2024 |
| 59898-720-01 | 59898-720 | Water-Jel Technologies | 1728 PACKET in 1 CARTON (59898-720-01) / .9 g in 1 PACKET | November 7, 2010 |
| 59898-720-02 | 59898-720 | Water-Jel Technologies | 144 PACKET in 1 BOX, UNIT-DOSE (59898-720-02) / .9 g in 1 PACKET | November 7, 2010 |
| 59898-720-03 | 59898-720 | Water-Jel Technologies | 25 PACKET in 1 BOX, UNIT-DOSE (59898-720-03) / .9 g in 1 PACKET | November 7, 2010 |
| 59898-720-36 | 59898-720 | Water-Jel Technologies | .9 g in 1 PACKET (59898-720-36) | November 7, 2010 |
| 50090-0815 | 50090-0815 | A-S Medication Solutions | — | June 20, 2011 |
| 50090-0845 | 50090-0845 | A-S Medication Solutions | — | June 20, 2011 |
| 84387-002 | 84387-002 | ALLIED TRADE LINK LLC | — | October 24, 2024 |
| 87236-000 | 87236-000 | AlderMed Inc. | — | November 1, 2025 |
| 68001-477 | 68001-477 | BluePoint Laboratories | — | November 24, 2020 |
| 71335-2731 | 71335-2731 | Bryant Ranch Prepack | — | June 20, 2011 |
| 72162-2280 | 72162-2280 | Bryant Ranch Prepack | — | June 20, 2011 |
| 59779-536 | 59779-536 | CVS Pharmacy | — | June 8, 2005 |
| 0713-0280 | 0713-0280 | Cosette Pharmaceuticals, Inc. | — | January 10, 1995 |
| 67777-116 | 67777-116 | Dynarex Corporation | — | September 12, 2016 |
| 37808-536 | 37808-536 | H E B | — | June 15, 1991 |
| 41226-880 | 41226-880 | Kroger | — | November 15, 2025 |
| 30142-536 | 30142-536 | Kroger Company | — | April 19, 2017 |
| 41250-844 | 41250-844 | Meijer Distribution Inc | — | October 24, 2018 |
| 68071-5253 | 68071-5253 | NuCare Pharmaceuticals,Inc. | — | January 10, 1995 |
| 45802-060 | 45802-060 | Padagis Israel Pharmaceuticals Ltd | — | June 20, 2011 |
| 68788-4153 | 68788-4153 | Preferred Pharmaceuticals Inc. | — | July 15, 2026 |
| 68788-8643 | 68788-8643 | Preferred Pharmaceuticals Inc. | — | April 30, 2024 |
| 68788-9794 | 68788-9794 | Preferred Pharmaceuticals, Inc | — | April 30, 2012 |
| 63187-299 | 63187-299 | Proficient Rx LP | — | December 1, 2009 |
| 71205-057 | 71205-057 | Proficient Rx LP | — | January 10, 1995 |
| 0536-1256 | 0536-1256 | RUGBY LABORATORIES | — | April 30, 2020 |
| 69396-027 | 69396-027 | Trifecta Pharmaceuticals USA, LLC. | — | March 15, 2017 |
| 59898-720 | 59898-720 | Water-Jel Technologies | — | November 7, 2010 |
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.