topcare hemorrhoidal

Product NDC: 36800-499
11-digit product format: 368000499
Labeler code: 36800
Product ID: 36800-499_9369a0f4-664f-4291-93bd-b4a23b72c9e8
Type: HUMAN OTC DRUG
Nonproprietary name: mineral oil, petrolatum, phenylephrine HCl
Dosage form: OINTMENT
Route: RECTAL
Labeler: Topco Associates LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-03-28
Substance: MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 14; 74.9; .25 g/100g; g/100g; g/100g
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 hemorrhoidal
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINERAL OIL	14 g/100g
PETROLATUM	74.9 g/100g
PHENYLEPHRINE HYDROCHLORIDE	.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
T5L8T28FGP	Internal UNII lookup
4T6H12BN9U	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1372298	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
615e87e4-79e0-44d6-b563-3bcd5a9b2d93	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-499-16	topcare hemorrhoidal	1 in 1 CARTON	OINTMENT	1		4
36800-499-16	topcare hemorrhoidal	57 g in 1 TUBE	OINTMENT	57		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
THYME OIL	INACTIVE INGREDIENT	2UK410MY6B	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-499	TOPCARE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [TOPCO ASSOCIATES LLC]	4	Current NDC, Legacy NDC, 2 package rows	20241019_615e87e4-79e0-44d6-b563-3bcd5a9b2d93.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 2 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Numb520Spray	LIDOCAINE, PHENYLEPHRINE HCL	Ebanel Laboratories, Inc.	350f0e25-fbdc-c0c0-e063-6294a90a50a0	2026-08-20	Warnings	Exact identifier application number: M015
Gembooxt Topical Numbing Cream	LIDOCAINE	Guangdong Quadrant Ecological Technology Co., Ltd.	49951a3e-3b62-3d66-e063-6294a90a9360	2026-08-12	Warnings	Exact identifier application number: M015
NumbMD Lidocaine Cream Anorectal(hemorrhoidal)	LIDOCAINE 5%	EveryMarket Inc	52379055-d017-4d98-e063-6294a90a196c	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD Lidocaine Cream	LIDOCAINE 5%	EveryMarket Inc	52369a41-820d-cd7a-e063-6394a90ac6d1	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD Lidocaine Cream	LIDOCAINE 5%	EveryMarket Inc	51d370b4-1c34-d203-e063-6394a90a80b1	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD 5% Lidocaine cream	LIDOCAINE 5%	EveryMarket Inc	507d0c2c-9517-40f8-e063-6394a90a1996	2026-08-12	Warnings	Exact identifier application number: M015
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)	LIDOCAINE CREAM ANORECTAL	EveryMarket Inc	483d81a3-7493-3391-e063-6394a90a2e3d	2026-08-12	Warnings	Exact identifier application number: M015
Numbing Cream	LIDOCAINE	100 KARMA INC	35b5ba9d-da1d-55d6-e063-6294a90a5fa8	2026-08-12	Warnings	Exact identifier application number: M015
Treatonic hemorrhoid treatment	5% LIDOCAINE	100 KARMA INC	41442fa7-c511-07ca-e063-6294a90a3992	2026-08-12	Warnings	Exact identifier application number: M015
Lidocaine numbing cream	5% LIDOCAINE	100 KARMA INC	47380721-6633-4a50-e063-6394a90aca94	2026-08-12	Warnings	Exact identifier application number: M015
Treatonic 5% Lidocaine Cream	5% LIDOCAINE CREAM	100 KARMA INC	47dc7630-9a74-1989-e063-6294a90a50bb	2026-08-12	Warnings	Exact identifier application number: M015
Treatonic 5% Lidocaine Cream	5% LIDOCAINE CREAM	100 KARMA INC	49e6b69f-bd6e-b415-e063-6394a90a8e65	2026-08-12	Warnings	Exact identifier application number: M015
Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing	LIDOCAINE	Putian Licheng District Zhijiancheng Trading Co., Ltd.	4a7be9eb-5e57-90e8-e063-6394a90aad9e	2026-08-08	Warnings	Exact identifier application number: M015
THE SOLU TION	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDE	SCALP TECH INC	58793581-8826-9a74-e063-6294a90a2465	2026-08-06	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	5457b3d7-e6b6-34a7-e063-6394a90aa240	2026-08-03	Warnings	Exact identifier application number: M015
HEMORRHOIDALCREAMPROCURE	PHENYLEPHRINE HCL, PETROLATUM, MINERAL OIL	TWIN MED, LLC	e9c44756-1c98-41be-e053-2995a90a35b4	2026-08-03	Warnings	Exact identifier application number: M015
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	YYBA CORP	582a0001-da1e-909a-e063-6394a90a2b11	2026-08-03	Warnings	Exact identifier application number: M015
up and up	PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	b42775ae-44fe-487e-b9ca-21d9687020a9	2026-07-29	Warnings	Exact identifier application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	578fa642-ff30-e511-e063-6294a90a5987	2026-07-26	Warnings	Exact identifier application number: M015
CVS Topical Anesthetic Hemorrhoidal	DIBUCAINE	CVS PHARMACY, INC	9f3d4fdb-ad82-4ab8-8a9e-252d027068ab	2026-07-25	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	615e87e4-79e0-44d6-b563-3bcd5a9b2d93	4
1372298	mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	615e87e4-79e0-44d6-b563-3bcd5a9b2d93	4
1372298	mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	615e87e4-79e0-44d6-b563-3bcd5a9b2d93	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-499-16	36800049916	1 TUBE in 1 CARTON (36800-499-16) / 57 g in 1 TUBE	1 tube	2014-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Hemorrhoidal Ointment Drug Facts	Topco Associates LLC	2024-10-16	HUMAN OTC DRUG LABEL	4