hemorrhoidal

Product NDC: 41250-279
11-digit product format: 412500279
Labeler code: 41250
Product ID: 41250-279_404c3dcd-ff0a-4d80-91a5-728b0054b23f
Type: HUMAN OTC DRUG
Nonproprietary name: cocoa butter, phenylephrine HCl
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Meijer Distribution Inc
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-10-08
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	41250-279	41250-279-67	D	Discontinued by firm		2026-10-15

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 · 10 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…`

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: 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
1431397e-3515-4794-a494-70667948e14c	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
41250-279-62	hemorrhoidal	1 in 1 BLISTER PACK	SUPPOSITORY	1	4
41250-279-62	hemorrhoidal	24 in 1 CARTON	SUPPOSITORY	24	4
41250-279-67	hemorrhoidal	48 in 1 CARTON	SUPPOSITORY	48	4
41250-279-67	hemorrhoidal	1 in 1 BLISTER PACK	SUPPOSITORY	1	4

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-279	HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [MEIJER DISTRIBUTION INC]	4	Current NDC, Legacy NDC, 4 package rows	20241102_1431397e-3515-4794-a494-70667948e14c.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 17 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DCH Rapid Relief Hemorrhoidal	LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Derma Care Research Labs	00eef84c-a72e-3343-e063-6294a90aa4d8	2024-12-19	Warnings	Exact identifier application number: M015
Formula 2 Skin Care	LIDOCAINE 5%	Derma Care Research Labs	a05d5e07-ae4b-38cc-e053-2a95a90abced	2024-12-19	Warnings	Exact identifier application number: M015
Revivol Hemorrhoid and Fissure	GLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%	Derma Care Research Labs, LLC	0140cf68-b6a0-4378-e063-6394a90afee8	2024-12-19	Warnings	Exact identifier application number: M015
Hemorroidal Cooling gel	PHENYLEPHRINE, WITCH HAZEL	Trifecta Pharmaceuticals Usa Llc	651c0143-384c-3649-e053-2991aa0a0f28	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	c50cc6ad-e8a0-47c1-e053-2a95a90a4de6	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	fe18fa61-83f9-8bf9-e053-6294a90a7585	2024-12-18	Warnings	Exact identifier application number: M015
HemorrhoidalOintment	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Trifecta Pharmaceuticals USA LLC	c59dcb2a-392b-670b-e053-2995a90a9682	2024-12-18	Warnings	Exact identifier application number: M015
TheraCare Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Veridian Healthcare	fab95657-d257-e671-e053-6294a90a59e0	2024-12-18	Warnings	Exact identifier application number: M015
TN Dickinsons Witch Hazel Hemorrhoidal Pads	WITCH HAZEL	Dickinson Brands Inc.	1b50f4dc-c26a-431a-ae18-c43513871b39	2024-12-18	Warnings	Exact identifier application number: M015
RECTICARE	LIDOCAINE	Ferndale Laboratories, Inc.	49cb48cf-7a26-4d7a-887f-2e98261d269d	2024-12-17	Warnings	Exact identifier application number: M015
Recticare Advanced	LIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUM	Ferndale Laboratories, Inc.	209212a7-7b6e-4b26-9f31-0eeb76f026bf	2024-12-17	Warnings	Exact identifier application number: M015
RECTICARE	LIDOCAINE AND GLYCERIN	Ferndale Laboratories, Inc.	2b94136a-4975-2925-e054-00144ff88e88	2024-12-17	Warnings	Exact identifier application number: M015
PRAX	PRAMOXINE HYDROCHLORIDE	Ferndale Laboratories, Inc.	674f0d8b-3d50-42b1-8401-d2967bcdf5cf	2024-12-17	Warnings	Exact identifier application number: M015
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI	Rugby	a5b5e0a9-eee9-2a1e-e053-2a95a90a464e	2024-12-17	Warnings	Exact identifier application number: M015
Warrior Rectal Care	LIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Derma Care Research Labs	fc10cbc3-fc1b-ae09-e053-6394a90ac8f3	2024-12-15	Warnings	Exact identifier application number: M015
Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)	GLYCERIN, LIDOCAINE, AND WITCH HAZEL	Blistex Inc	a7cb6d78-3048-43b3-afe7-4d862fdcfd3f	2024-12-13	Warnings	Exact identifier application number: M015
Tucks Medicated Cooling Pads	WITCH HAZEL	Blistex Inc	b3e68008-3d0d-4124-9579-b503e9fb95c9	2024-12-13	Warnings	Exact identifier application number: M015
T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal Relief	WITCH HAZEL	Dickinson Brands Inc.	2a4273a4-3bda-4653-a065-cd4578053f3c	2024-12-12	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	Medical Products Laboratories, Inc.	b815792f-2f8f-7ac8-e053-2995a90ade18	2024-12-11	Warnings	Exact identifier application number: M015
Zensa	LIDOCAINE	Alera Skin Care Products Inc.	f56146b6-3c11-4608-a6ab-6142f27e9ac3	2024-11-24	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	1431397e-3515-4794-a494-70667948e14c	4
1438497	cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository	SCD	1431397e-3515-4794-a494-70667948e14c	4
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	SY	1431397e-3515-4794-a494-70667948e14c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-279-62	41250027962	24 BLISTER PACK in 1 CARTON (41250-279-62) / 1 SUPPOSITORY in 1 BLISTER PACK	24 blister pack	2014-10-08	0000-00-00	No	No	Current
41250-279-67	41250027967	48 BLISTER PACK in 1 CARTON (41250-279-67) > 1 SUPPOSITORY in 1 BLISTER PACK	48 blister pack	2014-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Hemorrhoidal Suppositories Drug Facts	Meijer Distribution Inc	2024-10-18	HUMAN OTC DRUG LABEL	4