TopCare

Product NDC: 36800-381
11-digit product format: 368000381
Labeler code: 36800
Product ID: 36800-381_39ac8059-4dd6-6d84-e063-6294a90a8496
Type: HUMAN OTC DRUG
Nonproprietary name: Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: Topco Associates LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-03-21
Substance: NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength: 3.5; 10000; 10 mg/g; [iU]/g; mg/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: TopCare
Brand name suffix: Antibiotic Plus Pain Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEOMYCIN SULFATE	3.5 mg/g
POLYMYXIN B SULFATE	10000 [iU]/g
PRAMOXINE HYDROCHLORIDE	10 mg/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
19371312D4	Internal UNII lookup
88AYB867L5	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
55dc4025-f07f-41b2-8b18-6a11ee04b5cc	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
36800-381-01	TopCareAntibiotic Plus Pain Relief	1 in 1 CARTON	CREAM	1		4
36800-381-01	TopCareAntibiotic Plus Pain Relief	14.2 g in 1 TUBE	CREAM	14.2		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Neomycin Sulfate	ACTIVE INGREDIENT	057Y626693	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	1
Polymyxin B Sulfate	ACTIVE INGREDIENT	19371312D4	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	1
Pramoxine Hydrochloride	ACTIVE INGREDIENT	88AYB867L5	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	1
Neomycin	ACTIVE MOIETY	I16QD7X297	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	1
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	1
Pramoxine	ACTIVE MOIETY	068X84E056	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-381	TOPCARE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241114_55dc4025-f07f-41b2-8b18-6a11ee04b5cc.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 118 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	Patrin Pharma Inc.	91eedf9d-53b8-49d5-af59-25019606a0b2	2024-11-15	Warnings	Exact identifier application number: M017
equaline anti itch maximum strength	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	d1ac686e-62f2-4177-8abc-8c7ca578de1a	2024-11-15	Warnings	Exact identifier application number: M017
Meijer Pain Relieving Max Strength with Lavender Essential Oil Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	e688967e-799a-4fc8-a19a-f0012b90e76b	2024-11-15	Warnings	Exact identifier application number: M017
basic care hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	a0d0e82b-03ff-4d43-9be0-0e414ee49970	2024-11-15	Warnings	Exact identifier application number: M017
DG health hydrocortisone	HYDROCORTISONE	Dolgencorp, LLC	40710bae-32bb-47fd-b3dd-31d2c98ee70f	2024-11-15	Warnings	Exact identifier application number: M017
Meijer Ultra Strength Pain Relieving Topical Analgesic	CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE	Meijer Distribution, Inc	6319b019-8e17-4de1-b4e0-b402288a97d4	2024-11-15	Warnings	Exact identifier application number: M017
Meijer Pain Relieving analgesic	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	9953be94-5768-448f-83de-f5e53a2972cc	2024-11-15	Warnings	Exact identifier application number: M017
careone anti itch	HYDROCORTISONE	American Sales Company	5f7b1435-ebee-4093-847a-79e8d6641404	2024-11-15	Warnings	Exact identifier application number: M017
Tiger Balm	METHYL SALICYLATE AND MENTHOL	Haw Par Healthcare Ltd.	51293a06-5922-4072-ae14-afaba9c1b58e	2024-11-14	Warnings	Exact identifier application number: M017
Tylenol Precise Warming Pain Relieving	LIDOCAINE	Kenvue Brands LLC	0c60b607-ade9-68f2-e063-6394a90a4025	2024-11-13	Warnings	Exact identifier application number: M017
Tylenol Precise Pain Relieving	LIDOCAINE	Kenvue Brands LLC	fc1e0451-8c84-729e-e053-6394a90aaba0	2024-11-13	Warnings	Exact identifier application number: M017
Neosporin Plus Pain Relief First Aid Antibiotic/Pain Relieving	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	23222e54-d793-4d79-980e-550e32a95742	2024-11-13	Warnings	Exact identifier application number: M017
TopCare Pain Relieving Roll-On Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Topco Associates LLC	48589893-ca67-471d-88bc-92014295ab9f	2024-11-13	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	a1c1b878-d58f-41ff-b7a8-477f28c52667	2024-11-12	Warnings	Exact identifier application number: M017
Real Time Pain Relief Maxx Plus Topical Analgesic	MENTHOL	Real Time Products Inc.	fc509a55-594d-4d44-87db-33286e937581	2024-11-12	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Acme United Corporation	f1f051ad-7e82-9d1a-e053-2a95a90ac7d3	2024-11-12	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	ALLIED TRADE LINK LLC	26bc238d-3bda-0c29-e063-6394a90a35fb	2024-11-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Acme United Corporation	fabcaa3b-d189-bd29-e053-6294a90ae86b	2024-11-12	Warnings	Exact identifier application number: M017
ActivICE	MENTHOL	Medline Industries, LP	8414aea2-52b5-4221-e053-2a91aa0a622e	2024-11-12	Warnings	Exact identifier application number: M017
Pain Relieving Gel-Patch	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	26c7116f-c86d-8752-e063-6294a90ab73f	2024-11-12	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

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	55dc4025-f07f-41b2-8b18-6a11ee04b5cc	4
1359360	neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	55dc4025-f07f-41b2-8b18-6a11ee04b5cc	4
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	55dc4025-f07f-41b2-8b18-6a11ee04b5cc	4
1359360	neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical Cream	SY	55dc4025-f07f-41b2-8b18-6a11ee04b5cc	4
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	SY	55dc4025-f07f-41b2-8b18-6a11ee04b5cc	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-381-01	36800038101	1 TUBE in 1 CARTON (36800-381-01) / 14.2 g in 1 TUBE	1 tube	2012-03-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TopCare ® Antibiotic Plus Pain Relief	Topco Associates LLC \| Taro Pharmaceuticals U.S.A., Inc. \| Sun Pharma Canada Inc.	2025-07-11	HUMAN OTC DRUG LABEL	4