First Aid Antibiotic Bacitraycin Plus Maximum Strength

Product NDC: 47046-163
Requested package NDC: 47046-163-02
11-digit product format: 470460163
Labeler code: 47046
Product ID: 47046-163_b65eeccf-48e8-6769-e053-2a95a90a1956
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin and Pramoxine HCl
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Anicare Pharmaceuticals Pvt. Ltd
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2018-02-20
Marketing end: 0000-00-00
Substance: BACITRACIN; PRAMOXINE HYDROCHLORIDE
Active strength: 500 [USP'U]/g; mg/g
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	47046-163	47046-163-02	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
47046-163-02	2022-01-28	C162847	48780-1	d6a99b3a-0090-a426-e053-dadaa90af4c2	First Aid Antibiotic Bacitraycin Plus Maximum Strength Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47046-163-01	First Aid Antibiotic Bacitraycin Plus Maximum Strength	28 g in 1 TUBE	OINTMENT	28		1
47046-163-02	First Aid Antibiotic Bacitraycin Plus Maximum Strength	1 in 1 CARTON	OINTMENT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47046-163	FIRST AID ANTIBIOTIC BACITRAYCIN PLUS MAXIMUM STRENGTH (BACITRACIN AND PRAMOXINE HCL) OINTMENT [ANICARE PHARMACEUTICALS PVT. LTD]	1	Legacy NDC, 2 package rows	20201215_b65ee2ed-b506-7bcf-e053-2995a90ae10a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
58H6RWO52I	BACITRACIN	1405-87-4	BACITRACIN
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1303727	bacitracin 500 UNT / pramoxine HCl 10 MG per GM Topical Ointment	PSN	b65ee2ed-b506-7bcf-e053-2995a90ae10a	1
1303727	bacitracin 0.5 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment	SCD	b65ee2ed-b506-7bcf-e053-2995a90ae10a	1
1303727	bacitracin 500 UNT / pramoxine hydrochloride 10 MG per GM Topical Ointment	SY	b65ee2ed-b506-7bcf-e053-2995a90ae10a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47046-163-02	47046016302	1 TUBE in 1 CARTON (47046-163-02) > 28 g in 1 TUBE (47046-163-01)	1 tube	2018-02-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
First Aid Antibiotic Bacitraycin Plus Maximum Strength Ointment	Anicare Pharmaceuticals Pvt. Ltd	2020-12-13	HUMAN OTC DRUG LABEL	1