topcare hemorrhoidal

Product NDC: 36800-279
11-digit product format: 368000279
Labeler code: 36800
Product ID: 36800-279_4b69c540-9dad-4c55-b6e9-8d15dcd6e84c
Type: HUMAN OTC DRUG
Nonproprietary name: cocoa butter, phenylephrine HCl
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Topco Associates LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-11-03
Substance: COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 2211; 6.5 mg/1; mg/1
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-279	36800-279-62	D	Discontinued by firm		2026-09-14

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
COCOA BUTTER	2211 mg/1
PHENYLEPHRINE HYDROCHLORIDE	6.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
512OYT1CRR	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
1438497	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
81a3546b-5099-4b9a-b774-b3e79316b267	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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
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	SPL version
36800-279-53	topcare hemorrhoidal	1 in 1 BLISTER PACK	SUPPOSITORY	1	8
36800-279-53	topcare hemorrhoidal	12 in 1 CARTON	SUPPOSITORY	12	8
36800-279-62	topcare hemorrhoidal	24 in 1 CARTON	SUPPOSITORY	24	8
36800-279-62	topcare hemorrhoidal	1 in 1 BLISTER PACK	SUPPOSITORY	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-279-53	EA - Each	36800-279	9b462efb-0a21-49f2-a245-6eb734e321c1	1	2016-04-04
36800-279-62	EA - Each	36800-279	b11610e3-ff9d-4e7b-af32-4315b4ebf597	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COCOA BUTTER	ACTIVE INGREDIENT	512OYT1CRR	TOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	TOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]	2
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	TOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	TOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-279	TOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]	7	Current NDC, Legacy NDC, 4 package rows	20241024_81a3546b-5099-4b9a-b774-b3e79316b267.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 1 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flarestop Hemorrhoid Lidocaine	LIDOCAINE	Chelsea Pharmacceuticals LLC	b8a589f7-7131-4807-9bcb-84af3078e258	2026-09-10	Warnings	Exact identifier application number: M015
BCBCYC Numbing Cream	LIDOCAINE 5% NUMBING CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5ab36566-ba2f-06ef-e063-6394a90a71b5	2026-09-10	Warnings	Exact identifier application number: M015
5% Lidocaine 10g	5% LIDOCAINE	Chongqing Mandongzi Technology Co., Ltd	5b10530f-47cd-c4bd-e063-6294a90aaa0a	2026-09-09	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Rite Aid Corporation	407c78ca-6fee-4ed6-b61b-711ec049c86e	2026-09-09	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	CVS Pharmacy	3167c918-a7d3-46a1-a85b-64f9c22916f2	2026-09-04	Warnings	Exact identifier application number: M015
Flushable Hemorrhoidal Medicated Wipes Maximum Strength	WITCH HAZEL	Amazon.com Services LLC	41d756f3-e523-ed14-e063-6394a90ab817	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch Hazel	HEMORRHOIDAL WIPES WITH WITCH HAZEL	Better Living Brands LLC	adf26111-70ba-596c-e053-2995a90ac6f1	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
up and up medicated wipes manixim strength	GENTLE HEMORRHOIDAL CARE	Target Corporation	271eab2b-ed13-39f1-e054-00144ff88e88	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOE	WITCH HAZEL CLOTH	The Kroger Co.	48c1598d-6667-446f-ac90-10ab945d0617	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazel	WITCH HAZEL	Old East Main Co.	2055289d-962e-46a9-b371-b5bb93dd46b4	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Equate Hemorrhoidal Medicated Wipes	WITCH HAZEL	Walmart Inc.	8d57f054-77dc-4205-85f1-b65dcfde677b	2026-09-03	Warnings, Adverse reactions	Exact identifier application number: M015
Lidocaine Cream	LIDOCAINE	InvaDerm Corporation	5a7273d1-1dbc-420e-e063-6294a90a8629	2026-09-01	Warnings	Exact identifier application number: M015
Lidocaine Phenylephrine	LIDOCAINE PHENYLEPHRINE	YYBA CORP	5a72a190-2129-411e-e063-6394a90a08c2	2026-09-01	Warnings	Exact identifier application number: M015
INICEI 5% LIDOCAINE Numbing Cream	5% LIDOCAINE NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5a65842f-27a1-268b-e063-6294a90a6054	2026-08-31	Warnings	Exact identifier application number: M015
AnievaLC	LIDOCAINE	Blackstone Products, LLC	ddaba14c-10de-44e2-ae13-9217e20cb48e	2026-08-29	Warnings	Exact identifier application number: M015
Norms Hemorrhoid Wipes	WITCH HAZEL	Totally Normal Company	5a1af50b-8d00-f589-e063-6394a90af86c	2026-08-28	Warnings	Exact identifier application number: M015
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) Cream	LIDOCAINE	Guangzhou Hechuang Commercial Service Co.,Ltd.	59f0fa16-5eb0-e6bb-e063-6294a90aacf5	2026-08-26	Warnings	Exact identifier application number: M015
Dude Hemorrhoidal Wipes	WITCH HAZEL	Dude Products	fdf408ef-9392-a812-e053-6394a90a0017	2026-08-25	Warnings	Exact identifier application number: M015
Norms Medicated Wipes	WITCH HAZEL	Totally Normal Company	3a78e109-3f7c-fb19-e063-6394a90ae78e	2026-08-22	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	599b425a-0e96-76df-e063-6394a90a48ff	2026-08-21	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
512OYT1CRR	COCOA BUTTER	8002-31-1	COCOA BUTTER
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	PSN	81a3546b-5099-4b9a-b774-b3e79316b267	8
1438497	cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository	SCD	81a3546b-5099-4b9a-b774-b3e79316b267	8
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	SY	81a3546b-5099-4b9a-b774-b3e79316b267	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-279-53	36800027953	12 BLISTER PACK in 1 CARTON (36800-279-53) / 1 SUPPOSITORY in 1 BLISTER PACK	12 blister pack	2014-11-03	0000-00-00	No	No	Current
36800-279-62	36800027962	24 BLISTER PACK in 1 CARTON (36800-279-62) > 1 SUPPOSITORY in 1 BLISTER PACK	24 blister pack	2014-11-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Hemorrhoidal Suppositories Drug Facts	Topco Associates LLC	2025-12-13	HUMAN OTC DRUG LABEL	8