TRIBIOTIC

Product NDC: 50332-0032
11-digit product format: 503320032
Labeler code: 50332
Product ID: 50332-0032_9bdb3479-2b97-45d5-a82e-a5db1c149595
Type: HUMAN OTC DRUG
Nonproprietary name: BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: HART Health
Application: M
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-10-03
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50332-0032-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50332-0032-6	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50332-0032-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50332-0032-5	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50332-0032-4	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50332-0032-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50332-0032-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50332-0032-6	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50332-0032-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50332-0032-5	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50332-0032-4	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50332-0032-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50332-0032-3	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50332-0032-6	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50332-0032-1	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50332-0032-5	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50332-0032-4	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50332-0032-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50332-0032-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50332-0032-6	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50332-0032-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50332-0032-5	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50332-0032-4	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50332-0032-2	`8dfbde2a14a4…`	`c9ff85d89658…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: TRIBIOTIC
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	400 [iU]/g
NEOMYCIN SULFATE	3.5 mg/g
POLYMYXIN B SULFATE	5000 [iU]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89Y4M234ES	Internal UNII lookup
057Y626693	Internal UNII lookup
19371312D4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204602	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d8f175f9-f526-4c73-a171-49309ca16cb0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50332-0032-1	2022-11-28	TRIBIOTIC
50332-0032-2	2022-11-28	TRIBIOTIC
50332-0032-3	2022-11-28	TRIBIOTIC
50332-0032-4	2022-11-28	TRIBIOTIC
50332-0032-5	2022-11-28	TRIBIOTIC
50332-0032-6	2022-11-28	TRIBIOTIC
50332-0032-1	2021-01-29	TRIBIOTIC
50332-0032-2	2021-01-29	TRIBIOTIC
50332-0032-3	2021-01-29	TRIBIOTIC
50332-0032-4	2021-01-29	TRIBIOTIC
50332-0032-5	2021-01-29	TRIBIOTIC
50332-0032-6	2021-01-29	TRIBIOTIC

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]	1
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]	1
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]	1
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50332-0032	TRIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [HART HEALTH]	5	Current NDC, Legacy NDC	20240119_d8f175f9-f526-4c73-a171-49309ca16cb0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menthol Pain Relieving Cream with Menthol 10%	MENTHOL 10% CREAM	ONE2ZEE LIMITED LIABILITY COMPANY	ae09e93f-3988-4477-ae53-b2f3df9769fb	2025-05-05	Warnings	Exact identifier application number: M
Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ENGLEWOOD LAB, INC.	edf07b7f-46fb-4915-b2ea-83d852617f60	2025-04-10	Warnings	Exact identifier application number: M
BRONCOCHEM KIDS COLD AND FLU	ACETAMINOPHEN-PHENYLEPHRINE HCL-GUAIFENESIN	LABORATORIO MAGNACHEM INTERNATIONAL SRL	b6559fb9-2dea-49c0-a274-3e77741a0ffd	2025-03-23	Warnings	Exact identifier application number: M
BRONCOCHEM MAXIMUM COUGH	DEXTROMETHORPHAN HBR-GYAIFENESIN	LABORATORIO MAGNACHEM INTERNATIONAL SRL	deecdb72-4cdb-4d6f-972f-a425a91afa5a	2025-03-23	Warnings	Exact identifier application number: M
BRONCOCHEM MAXIMUM COUGH NIGHT	DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE	LABORATORIO MAGNACHEM INTERNATIONAL SRL	dffdfa2c-a52e-4606-9b07-c8993e499f09	2025-03-23	Warnings	Exact identifier application number: M
BRONCOCHEM EXPECTORANT II	ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCL	LABORATORIO MAGNACHEM INTERNATIONAL SRL	1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a	2025-03-23	Warnings	Exact identifier application number: M
BRONCOCHEM MAXIMUM COUGH KIDS	DEXTROMETHORPHAN HBR-GUAIFENESIN	LABORATORIO MAGNACHEM INTERNATIONAL SRL	b0fd2f2f-5cc4-4813-8f99-c78fbe898656	2025-03-13	Warnings	Exact identifier application number: M
Menthol Pain Relief Gel Patch	MENTHOL PAIN RELIEF GEL PATCH	ONE2ZEE LIMITED LIABILITY COMPANY	eab185d6-2a54-489d-8114-fe8088624ba4	2025-03-04	Warnings	Exact identifier application number: M
Lidocaine 4% Pain Relief Gel Patch	LIDOCAINE 4% PAIN RELIEF GEL PATCH	ONE2ZEE LIMITED LIABILITY COMPANY	8e5a4ef4-b928-44b3-842c-92f1531af75b	2025-03-03	Warnings	Exact identifier application number: M
gas relief	SIMETHICONE	Strategic Sourcing Services LLC	23005295-c5f2-4a76-8431-4a9b8d817d4d	2025-01-03	Warnings	Exact identifier application number: M
Foster and Thrive infants Gas relief	SIMETHICONE	Strategic Sourcing Services LLC	824c9dff-0a26-4710-a25b-39df631d6fa6	2024-12-13	Warnings	Exact identifier application number: M
BRONCOCHEM COLD AND FLU TEA	ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE	LABORATORIO MAGNACHEM INTERNATIONAL SRL	b7d3f54e-59ef-4b85-a88d-b053058dc1f6	2024-12-12	Warnings	Exact identifier application number: M
HYSAN PAIN RELIEVER	METHYL SALICYLATE, CAMPHOR (SYNTHETIC)	HYSAN PHARMACEUTICAL CO LTD	bad73234-c204-40a8-8176-45c75ae500c8	2024-10-07	Warnings	Exact identifier application number: M
HYSAN ANALGESIC	METHYL SALICYLATE, CAMPHOR (SYNTHETIC)	HYSAN PHARMACEUTICAL CO LTD	99a13b0a-1d77-479e-ba99-2cfa638de339	2024-10-04	Warnings	Exact identifier application number: M
HYSAN HUO LU MEDICATED	METHYL SALICYLATE, CAMPHOR (SYNTHETIC)	HYSAN PHARMACEUTICAL CO LTD	fe9eeaff-fcbf-4287-9f17-bcf1822bf35b	2024-10-04	Warnings	Exact identifier application number: M
HYSAN HUA TUO MEDICATED	METHYL SALICYLATE	HYSAN PHARMACEUTICAL CO LTD	b84c4d33-5a77-46e0-b04e-32f73967bd1c	2024-10-04	Warnings	Exact identifier application number: M
HYSAN HUA TUO HUO LU	METHYL SALICYLATE, CAMPHOR (SYNTHETIC)	HYSAN PHARMACEUTICAL CO LTD	cd2288c4-9909-43c1-91da-b15545b09788	2024-10-04	Warnings	Exact identifier application number: M
CLARINS - ROLL-ON DEODORANT Aluminum Chlorohydrate - Antiperspirant, Long-lasting Alcohol-free	ALUMINUM CHLOROHYDRATE	Laboratoires Clarins	412116a1-f9af-4c03-85e0-aad5738dd797	2024-08-05	Warnings	Exact identifier application number: M
BRONCOCHEM MAXIMUM COUGH NIGHT	DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE	LABORATORIO MAGNACHEM INTERNATIONAL SRL	1a3ed214-e09b-4266-b68b-39e7c3127d26	2024-04-22	Warnings	Exact identifier application number: M
CLARUS Antifungal	TOLNAFTATE	Clinical Therapeutic Solutions	835c3c23-fc3c-404e-8e87-5a0176126730	2024-02-28	Warnings	Exact identifier application number: M

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	d8f175f9-f526-4c73-a171-49309ca16cb0	5
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	d8f175f9-f526-4c73-a171-49309ca16cb0	5
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	d8f175f9-f526-4c73-a171-49309ca16cb0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50332-0032-1	50332003201	10 PACKET in 1 BOX, UNIT-DOSE (50332-0032-1) / .9 g in 1 PACKET	10 packet	2005-10-03	0000-00-00	No	No	Current
50332-0032-2	50332003202	25 PACKET in 1 BOX, UNIT-DOSE (50332-0032-2) / .9 g in 1 PACKET	25 packet	2005-10-03	0000-00-00	No	No	Current
50332-0032-3	50332003203	25 PACKET in 1 BOX, UNIT-DOSE (50332-0032-3) / .5 g in 1 PACKET	25 packet	2005-10-03	0000-00-00	No	No	Current
50332-0032-4	50332003204	144 PACKET in 1 BOX, UNIT-DOSE (50332-0032-4) / .9 g in 1 PACKET	144 packet	2005-10-03	0000-00-00	No	No	Current
50332-0032-5	50332003205	144 PACKET in 1 BOX, UNIT-DOSE (50332-0032-5) / .5 g in 1 PACKET	144 packet	2005-10-03	0000-00-00	No	No	Current
50332-0032-6	50332003206	10 PACKET in 1 BOX, UNIT-DOSE (50332-0032-6) / .5 g in 1 PACKET	10 packet	2005-10-03	0000-00-00	No	No	Current