Walgreens Hemorrhoidal

Product NDC: 0363-0476
Requested package NDC: 0363-0476-24
11-digit product format: 003630476
Labeler code: 0363
Product ID: 0363-0476_48644028-e157-a563-e063-6294a90aa33f
Type: HUMAN OTC DRUG
Nonproprietary name: Hemorrhoidal Rectal Suppositories
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Walgreens
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-09-18
Substance: COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 2211; 6.25 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0363-0476	0363-0476-24	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0363-0476	0363-0476-24	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0363-0476	0363-0476-24	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`

Additional Listing Data#

Finished product: Yes
Brand name base: Walgreens Hemorrhoidal
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COCOA BUTTER	2211 mg/1
PHENYLEPHRINE HYDROCHLORIDE	6.25 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
2dd710ac-ab04-4a24-826f-b5a44d058168	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
0363-0476-12	2024-02-06	d6a99b39-e7db-a426-e053-dadaa90af4c2	WALGREENS HEMORRHOIDAL SUPPOSITORIES
0363-0476-24	2024-02-06	d6a99b3a-00e6-a426-e053-dadaa90af4c2	WALGREENS HEMORRHOIDAL SUPPOSITORIES
0363-0476-12	2022-01-28	d6a99b39-e7db-a426-e053-dadaa90af4c2	WALGREENS HEMORRHOIDAL SUPPOSITORIES
0363-0476-24	2022-01-28	d6a99b3a-00e6-a426-e053-dadaa90af4c2	WALGREENS HEMORRHOIDAL SUPPOSITORIES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0476-12	Walgreens Hemorrhoidal	2 in 1 CARTON	SUPPOSITORY	2	7
0363-0476-13	Walgreens Hemorrhoidal	6 in 1 BLISTER PACK	SUPPOSITORY	6	7
0363-0476-24	Walgreens Hemorrhoidal	4 in 1 CARTON	SUPPOSITORY	4	7
0363-0476-25	Walgreens Hemorrhoidal	6 in 1 BLISTER PACK	SUPPOSITORY	6	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0476	WALGREENS HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [WALGREENS]	5	Current NDC, Legacy NDC, 2 package rows	20250112_2dd710ac-ab04-4a24-826f-b5a44d058168.zip
0363-0476	WALGREENS HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [WALGREENS]	5	Current NDC, Legacy NDC, 2 package rows	20250112_ca98dea5-767d-49a8-887b-d96cad487fc4.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 22 · 422 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Moisture Barrier	MENTHOL 0.44%, ZINC OXIDE 20.6%	Walgreen Company	258f3392-0f42-21e8-e063-6294a90ae9ad	2026-07-22	Warnings	Exact identifier application number: M015
RectaEase Hemorrhoid Relief Cream	LIDOCAINE	Trifecta Pharmaceuticals USA LLC	c054921a-9f1b-7c75-e053-2995a90a1738	2026-07-20	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	KORVIA GLOBAL Inc.	5690db03-4d62-9660-e063-6394a90a2fc0	2026-07-14	Warnings	Exact identifier application number: M015
Gembooxt Topical Numbing Cream	LIDOCAINE HCL	Guangdong Quadrant Ecological Technology Co., Ltd.	49951a3e-3b62-3d66-e063-6294a90a9360	2026-07-13	Warnings	Exact identifier application number: M015
Zmztuhua Numbing Cream	LIDOCAINE	Guangzhou Hechuang Commercial Service Co.,Ltd.	56417dc6-c14b-ad17-e063-6294a90af7e5	2026-07-10	Warnings	Exact identifier application number: M015
Tina Davies IceCream	LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	TINA DAVIES PROFESSIONAL LLC	6a2b3199-f405-4455-9a02-8885d24eef9c	2026-07-09	Warnings	Exact identifier application number: M015
Drs pharmacy HEMORRHOIDAL	PHENYLEPHRINE HCL, WITCH HAZEL	OL PHARMA TECH, LLC Drs PHARMACY	164169b9-0627-9d1a-e063-6294a90ac46d	2026-07-09	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	H E B	09b814f4-86b5-4810-bf52-cc88396451c2	2026-07-07	Warnings, Adverse reactions	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	ADUSA Distribution, LLC	c50d0496-6f09-43c2-9383-3250885968c9	2026-06-29	Warnings, Adverse reactions	Exact identifier application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	55260a3e-637a-c53b-e063-6394a90a1b09	2026-06-27	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal	HEMORRHOIDAL RECTAL SUPPOSITORIES	Walgreens	20c41406-99b2-bc89-e063-6294a90aed73	2026-06-25	Warnings	Exact identifier application number: M015
CalaSoothe	CALAMINE, MENTHOL, AND ZINC OXIDE	Dynarex Corporation	54f12005-acfe-4821-e063-6394a90ac304	2026-06-24	Warnings	Exact identifier application number: M015
tina davies IceCream Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	TINA DAVIES PROFESSIONAL LLC	10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd	2026-06-24	Warnings	Exact identifier application number: M015
Haemorrhoidal Pain Relief	ANORECTAL CREAM	NeilMed Pharmaceuticals Inc	544a9d6f-4eaa-613e-e063-6294a90a0c50	2026-06-15	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	5457b3d7-e6b6-34a7-e063-6394a90aa240	2026-06-15	Warnings	Exact identifier application number: M015
Dr.Seymour Butts Hemorrhoid	LIDOCAINE5% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4981c7d9-53ee-2a7b-e063-6394a90add01	2026-06-12	Warnings	Exact identifier application number: M015
ANIXIKE Numbing	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4d5b7c4c-feac-4eeb-e063-6294a90a5748	2026-06-11	Warnings	Exact identifier application number: M015
tina davies IceJelly Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	TINA DAVIES PROFESSIONAL LLC	580559bf-d91f-4bb3-9c9b-b7e2cd0686fd	2026-06-11	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	2dd710ac-ab04-4a24-826f-b5a44d058168	7
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	PSN	ca98dea5-767d-49a8-887b-d96cad487fc4	7
1438497	cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository	SCD	2dd710ac-ab04-4a24-826f-b5a44d058168	7
1438497	cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository	SCD	ca98dea5-767d-49a8-887b-d96cad487fc4	7
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	SY	2dd710ac-ab04-4a24-826f-b5a44d058168	7
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	SY	ca98dea5-767d-49a8-887b-d96cad487fc4	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0476-24	00363047624	4 BLISTER PACK in 1 CARTON (0363-0476-24) / 6 SUPPOSITORY in 1 BLISTER PACK (0363-0476-25)	4 blister pack	2020-04-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
WALGREENS HEMORRHOIDAL SUPPOSITORIES	Walgreens \| Unipack LLC	2026-01-14	HUMAN OTC DRUG LABEL	7
WALGREENS HEMORRHOIDAL SUPPOSITORIES	Walgreens \| Unipack LLC	2026-01-14	HUMAN OTC DRUG LABEL	7