Walgreens Hemorrhoidal

Product NDC: 0363-0476
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0363-0476-24	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0363-0476-12	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0363-0476-24	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0363-0476-12	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0363-0476-24	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0363-0476-12	`bd6a592717d7…`	`303034d00443…`

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: 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 14 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	4eb3c9ac-268a-5246-e054-00144ff88e88	2025-06-09	Warnings	Exact identifier application number: M015
Bunnies Bum Anorectal Numbing	LIDOCAINE	FloCal Distributors LLC	3712e151-d171-1c5d-e063-6294a90a36c0	2025-06-08	Warnings	Exact identifier application number: M015
RECOVERY Numbing	LIDOCAINE HCL	Renu Laboratories, LLC	e4e05cae-56a6-b2b3-e053-2a95a90a104b	2025-06-06	Warnings	Exact identifier application number: M015
Hemorrohoid Master Cream	LIDOCAINE, PHENYLEPHRINE HCL	Ebanel Laboratories, Inc.	36eccc74-107e-3914-e063-6294a90a1856	2025-06-06	Warnings	Exact identifier application number: M015
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	36c9988b-9e61-ebbf-e063-6394a90a4114	2025-06-04	Warnings	Exact identifier application number: M015
Hemorrhoid Master	LIDOCAINE, PHENYLEPHRINE HCL	Clinical Resolution Laboratory, Inc.	36caf20d-116a-f86a-e063-6294a90a7b62	2025-06-04	Warnings	Exact identifier application number: M015
Quick Numb	LIDOCAINE	Clinical Resolution Laboratory, Inc.	351b95a6-e038-d9aa-e063-6294a90a4172	2025-05-29	Warnings	Exact identifier application number: M015
Dibucaine Topical Anesthetic 1% Hemorrhoidal	DIBUCAINE	Rugby Laboratories Inc.	f23c8cd1-98f9-41cd-84d4-cf01c2ede29a	2025-05-29	Warnings	Exact identifier application number: M015
The Femme Fix Hemorrhoid Treatment	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	POPPY COLLECTIVE LLC	5217b5d9-b835-4428-a6b3-e6b255630742	2025-05-27	Warnings	Exact identifier application number: M015
MAXOCAINE Topical Anesthetic Anorectal	LIDOCAINE	PRIME COMMERCE, LLC	26e8c867-8cb8-4a25-91b1-da45a1edd09a	2025-05-27	Warnings	Exact identifier application number: M015
Numb25	LIDOCAINE	Ebanel Laboratories, Inc.	35107403-55ae-c627-e063-6394a90a0b5c	2025-05-27	Warnings	Exact identifier application number: M015
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	350e4d5e-dac7-ae4e-e063-6394a90a76b4	2025-05-27	Warnings	Exact identifier application number: M015
Numb25	LIDOCAINE 5%	Ebanel Laboratories, Inc	350fd302-8fd5-5288-e063-6294a90aa382	2025-05-27	Warnings	Exact identifier application number: M015
Numb 520	LIDOCAINE	Ebanel Laboratories, Inc	35095bed-0e91-c44a-e063-6294a90add6e	2025-05-27	Warnings	Exact identifier application number: M015
Numb520	LIDOCAINE	Clinical Resolution Laboratory, Inc.	a0411950-c6ee-4427-acb6-3cef58b0e93e	2025-05-15	Warnings	Exact identifier application number: M015
Numb25	LIDOCAINE	Clinical Resolution Laboratory, Inc.	cfcb839d-47b4-4925-bb30-97b64d20d2b3	2025-05-15	Warnings	Exact identifier application number: M015
Numb520	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Clinical Resolution Laboratory, Inc.	65d3b614-361d-4fb9-9583-a95be754bc82	2025-05-15	Warnings	Exact identifier application number: M015
Chamosyn	BARRIER CREAM	Links Medical Products	f9dfb2d7-4684-4525-994e-1e0ff90413d9	2025-05-08	Warnings	Exact identifier application number: M015
LANOZEM HEMORRHOIDAL	MENTHOL, PETROLATUM	Sod-e Biotech Ltd	34901e83-8f24-8460-e063-6394a90a2744	2025-05-07	Warnings	Exact identifier application number: M015
PREPARATION H	PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	96d2e0e7-2de0-4660-9ffd-9edb2ad224d8	2025-04-18	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
0363-0476-12	00363047612	2 BLISTER PACK in 1 CARTON (0363-0476-12) / 6 SUPPOSITORY in 1 BLISTER PACK (0363-0476-13)	2 blister pack	2017-09-17	0000-00-00	No	No	Current
0363-0476-13	00363047613	6 in 1 BLISTER PACK						Historical
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
0363-0476-25	00363047625	6 in 1 BLISTER PACK						Historical

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