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 131 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HealthWise Feminine Anti-itch Cream	BENZOCAINE, RESORCINOL	Veridian Healthcare	19fe7c3b-58e2-6c16-e063-6394a90a612a	2024-06-03	Warnings	Exact identifier application number: M017
THE SOLUTION NUMBING	LIDOCAINE HYDROCHLORIDE	SCALP TECH INC	184be4cc-b0b9-7882-e063-6394a90a8e7e	2024-05-25	Warnings	Exact identifier application number: M017
Methyl Salicylate 25 Percent	METHYL SALICYLATE	Alexso, Inc	d8b8b0ba-69e9-4965-bf9b-6db21db69b34	2024-05-23	Warnings	Exact identifier application number: M017
Meijer Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Meijer Distribution	07ecc6a7-bbe3-35cf-e063-6394a90a2180	2024-05-22	Warnings	Exact identifier application number: M017
TheraCare Hydrocortisone Cream	HYDROCORTISONE	Veridian Healthcare	01cb7b47-2c3c-707d-e063-6294a90a5d97	2024-05-21	Warnings	Exact identifier application number: M017
TheraCare 4% Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	c808aa05-9d49-cc9f-e053-2a95a90a50f3	2024-05-21	Warnings	Exact identifier application number: M017
TheraCare 4% Lidocaine and 1% Menthol Cream	MENTHOL AND LIDOCAINE	Veridian Healthcare	c80ba251-91a5-0858-e053-2995a90a9cff	2024-05-21	Warnings	Exact identifier application number: M017
HealthWise Menthol Roll-On	MENTHOL	Veridian Healthcare	102d57a5-6449-f825-e063-6294a90a8844	2024-05-21	Warnings	Exact identifier application number: M017
SAFLY Burn	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	3aca2568-d10f-4b14-861b-6c741c106829	2024-05-17	Warnings	Exact identifier application number: M017
HealthWise Menthol 4% Roll-On	MENTHOL	Veridian Healthcare	1894ef00-ba05-0e02-e063-6394a90ab982	2024-05-16	Warnings	Exact identifier application number: M017
Leader Poison Ivy Wash	PRAMOXINE HYDROCHLORIDE LOTION	Cardinal Health, 110 dba Leader	81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c	2024-05-13	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	0e808f89-62dc-3790-e063-6394a90a2351	2024-05-13	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Plus Cream	BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE	Walgreens Company	e33e0097-31d6-8083-e053-2a95a90af5d2	2024-05-09	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold Gel	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1794c512-5f42-4ec3-e063-6394a90a87cd	2024-05-03	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro	MENTHOL AND CAMPHOR	ACTIVE AND INNOVATIVE, LLC	17961a84-6bee-c75f-e063-6394a90af576	2024-05-03	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Pain Relieving Creme	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd	2024-05-01	Warnings	Exact identifier application number: M017
Lidocaine HCl 4 Percent	LIDOCAINE HYDROCHLORIDE	ARI BRANDS, LLC	81aff5c5-91c0-4173-a432-d20115613580	2024-04-30	Warnings	Exact identifier application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 Bulk	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	17545078-05e1-9338-e063-6394a90a678c	2024-04-30	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pro Roll-on	CAMPHOR, MENTHOL	ACTIVE AND INNOVATIVE, LLC	1755ec89-c404-1c17-e063-6394a90ab9fb	2024-04-30	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Roll On	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bc2a14-6bda-428c-e053-2995a90a4ced	2024-04-29	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