antibiotic

Product NDC: 37808-005
11-digit product format: 378080005
Labeler code: 37808
Product ID: 37808-005_9fd3e906-9a3a-4640-aff6-8237eb1c5980
Type: HUMAN OTC DRUG
Nonproprietary name: Neomycin, Polymyxin B, Pramoxine HCl
Dosage form: CREAM
Route: TOPICAL
Labeler: H E B
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-09-14
Substance: NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE
Active strength: 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: antibiotic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEOMYCIN SULFATE	3.5 mg/g
PRAMOXINE HYDROCHLORIDE	10 mg/g
POLYMYXIN B SULFATE	10000 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
057Y626693	Internal UNII lookup
88AYB867L5	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
1359360	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
55fa94cb-7e1c-41bc-879a-5618a828f14a	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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37808-005-58	antibiotic	1 in 1 CARTON	CREAM	1		3
37808-005-58	antibiotic	14 g in 1 TUBE	CREAM	14		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-005	ANTIBIOTIC (NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL) CREAM [H E B]	3	Current NDC, Legacy NDC, 2 package rows	20241016_55fa94cb-7e1c-41bc-879a-5618a828f14a.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 19 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATE	Universal Distribution Center LLC	78f00296-267b-44c3-a9e3-c40f122e905e	2024-05-14	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	JHK Inc dba American Safety & First Aid	26e66025-9457-42b3-9319-51302c17506e	2024-04-26	Warnings	Exact identifier application number: M004
Hydrogen Peroxide	HYDROGEN PEROXIDE	JHK Inc	1472c854-09c8-4ad8-b8a6-0235440ac26b	2024-04-26	Warnings	Exact identifier application number: M004
Isopropyl Alcohol	ISOPROPYL ALCOHOL	JHK Inc	abae6a80-e859-47b5-8e34-d391eb854583	2024-04-26	Warnings	Exact identifier application number: M004
Antiseptic	BENZALKONIUM CHLORIDE, BENZOCAINE	JHK Inc	0ac5d890-c262-4a30-9fd8-2de6cb0f7601	2024-04-25	Warnings	Exact identifier application number: M004
First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	M-star (Hubei) Health&Care Products Co., Ltd.	c6f2656e-b822-4d61-b557-dd2046dd51f5	2024-04-01	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE	CVS PHARMACY, INC	32e92acf-2e48-4933-8e08-e1df650e7d19	2024-03-15	Warnings	Exact identifier application number: M004
Major Bacitracin	BACITRACIN	Major Pharmaceuticals	13288efb-e282-68f8-e063-6294a90ae712	2024-03-08	Warnings	Exact identifier application number: M004
UniShield TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unishield	00b85d3a-322b-43c1-b022-5f6ed50c6609	2024-03-02	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Chain Drug Marketing Association Inc.	1277942d-753f-ab69-e063-6394a90a496a	2024-02-28	Warnings	Exact identifier application number: M004
Triple Antibiotic with Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	Safetec of America, Inc.	ca1df4a0-844d-4b1d-b972-f2704a8ebbab	2024-02-16	Warnings	Exact identifier application number: M004
Single Antibiotic	BACITRACIN ZINC	Safetec of America, Inc.	9993c204-6e61-4da3-90ef-2b7dfa09c920	2024-02-14	Warnings	Exact identifier application number: M004
Single Antibiotic with Neomycin	NEOMYCIN SULFATE	Safetec of America	e989cf7e-f3d1-42d2-af45-fc80095b97cb	2024-02-08	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	96c41fc1-81f9-4757-abc6-867b5383ed5d	2024-02-07	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	2c2aa8af-2adb-4f59-ac20-15818d0e28e7	2024-02-07	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	03c05028-5a5f-4690-a836-cc1b1044ab39	2024-02-05	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Safetec of America, Inc.	59494d5c-dd8a-431c-8e6a-4e1151ba7460	2024-02-05	Warnings	Exact identifier application number: M004
Triple Antibiotic	FIRST AID ANTIBIOTIC	BluePoint Laboratories	c47e15bd-1062-4cca-e053-2995a90a9075	2024-01-31	Warnings	Exact identifier application number: M004
Neomycin	NEOMYCIN OINTMENT	Dynarex Corporation	0f9e087b-6e86-a3c7-e063-6394a90ac8d4	2024-01-23	Warnings	Exact identifier application number: M004
Antibiotic and Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Target Corporation	050be94c-1fbb-4d84-82c6-841aac8f318e	2024-01-18	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE
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
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	PSN	55fa94cb-7e1c-41bc-879a-5618a828f14a	3
1359360	neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	55fa94cb-7e1c-41bc-879a-5618a828f14a	3
1359360	neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical Cream	SY	55fa94cb-7e1c-41bc-879a-5618a828f14a	3
1359360	neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical Cream	SY	55fa94cb-7e1c-41bc-879a-5618a828f14a	3
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	SY	55fa94cb-7e1c-41bc-879a-5618a828f14a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-005-58	37808000558	1 TUBE in 1 CARTON (37808-005-58) / 14 g in 1 TUBE	1 tube	2015-09-14	0000-00-00	No	No	Current