PREPARATION H

Product NDC: 0573-2880
11-digit product format: 005732880
Labeler code: 0573
Product ID: 0573-2880_12ad4740-7bea-f822-e063-6394a90a0e38
Type: HUMAN OTC DRUG
Nonproprietary name: cocoa butter, phenylephrine hydrochloride
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Haleon US Holdings LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-01-05
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: 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	0573-2880	0573-2880-31	D	Discontinued by firm		2026-10-12

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0573-2880-31	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0573-2880-31	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0573-2880-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0573-2880-31	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0573-2880-31	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0573-2880-31	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0573-2880-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0573-2880-31	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0573-2880-31	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0573-2880-31	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0573-2880-31	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0573-2880-31	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0573-2880-31	I	Inactivated by FDA	`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: PREPARATION H
Listing expiration: 2026-12-31

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
a23ded81-78ba-c199-a8f0-aaf360b216ff	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0573-2880-31	2023-05-17	C162847	48780-1	d6a99b39-b3f3-a426-e053-dadaa90af4c2	Drug Facts
0573-2880-31	2022-01-28	C162847	48780-1	d6a99b39-b3f3-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0573-2880-31	PREPARATION H	48 in 1 CARTON	SUPPOSITORY	48		18
0573-2880-31	PREPARATION H	1 in 1 BLISTER PACK	SUPPOSITORY	1		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-2880-31	EA - Each	0573-2880	c7587702-585d-4f4a-b748-54226a6e71c8	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COCOA BUTTER	ACTIVE INGREDIENT	512OYT1CRR	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-2880	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [HALEON US HOLDINGS LLC]	18	Current NDC, Legacy NDC, 2 package rows	20240303_a23ded81-78ba-c199-a8f0-aaf360b216ff.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 5 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DRMITSUI MEDICAL HAEMORRHOID	PHENYLEPHRINE HCI WITCH HAZEL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	51720221-893b-cade-e063-6394a90adaec	2026-05-10	Warnings	Exact identifier application number: M015
Glycerin	GLYCERIN SUPPOSITORIES	Neilmed Pharmaceuticals Inc.	374a2ca3-ee04-09a7-e063-6394a90ab760	2026-05-05	Warnings	Exact identifier application number: M015
Dr. Numb	LIDOCAINE	Shinpharma Inc	32ab24b4-dcec-4a09-e054-00144ff88e88	2026-04-30	Warnings	Exact identifier application number: M015
Dr. Numb	LIDOCAINE	Shinpharma Inc	c2c0cb17-401a-4ba2-aa04-64c9b43cd21b	2026-04-30	Warnings	Exact identifier application number: M015
Dr. Numb	LIDOCAINE	Shinpharma Inc	e840fba4-86ff-9da0-e053-2995a90a221a	2026-04-30	Warnings	Exact identifier application number: M015
FAMILY Wellness MEDICATED HEMORRHOIDAL WIPES	WITCH HAZEL	Family Dollar Stores, Inc	3f6f68c0-787a-48eb-b042-d4df90ea7e03	2026-04-17	Warnings	Exact identifier application number: M015
Equaline Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	a6ed1987-37ad-4bfd-8cea-f03426953f5a	2026-04-16	Warnings	Exact identifier application number: M015
Verdibliss HEMORRHOID RELIEF OINTMENTS	LIDOCAINE, PHENYLEPHRINE	Guangdong Quadrant Ecological Technology Co., Ltd.	4f1634d5-7667-b354-e063-6394a90a34e7	2026-04-10	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream with Lidocaine	GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM	Trifecta Pharmaceuticals Usa Llc	4f1ef866-c4af-989b-e063-6294a90a148e	2026-04-10	Warnings	Exact identifier application number: M015
Thera Plus Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM	Fourstar Group USA, Inc.	5d63bf97-29d2-4c71-97c3-85f425e86207	2026-04-07	Warnings	Exact identifier application number: M015
Walgreens Pain Relief with Lidocaine	LIDOCAINE, PHENYLEPHRINE HCL	Walgreens Co	3ce78f2f-0264-f406-e063-6294a90a7e03	2026-04-01	Warnings	Exact identifier application number: M015
Lidocaine	LIDOCAINE	YYBA Corp	5256a84a-8dac-8fd4-e063-6294a90a616c	2026-04-01	Warnings	Exact identifier application number: M015
Hemorrhoidal	LIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUM	Walgreens Co	3d213ba8-3cbe-11c4-e063-6394a90ae016	2026-03-30	Warnings	Exact identifier application number: M015
Critic Aid Skin	ZINC OXIDE	Coloplast Corp	caaac1f0-437d-4185-8670-9f11b9cefe63	2026-03-30	Warnings	Exact identifier application number: M015
CVS Topical Analgesic Hemorrhoidal	DIBUCAINE	CVS PHARMACY,INC	b9e20531-3444-4955-b1d3-bb112340d230	2026-03-27	Warnings	Exact identifier application number: M015
Walgreens Moisture Barrier	WALGREENS MOISTURE BARRIER	Walgreens	44fc098c-1f5f-bf82-e063-6294a90a1405	2026-03-25	Warnings	Exact identifier application number: M015
Lidocaine	LIDOCAINE	YYBA Corp	472fe0d1-31a1-fded-e063-6394a90a4a66	2026-03-25	Warnings	Exact identifier application number: M015
Hemorrhoid Relief Cream	LIDOCAINE 5% ANORECTAL	ALAINA HEALTHCARE PRIVATE LIMITED	53b2c3b0-d729-44d6-bc64-a9e1c9351877	2026-03-23	Warnings	Exact identifier application number: M015
LIDOCAINE	LIDOCAINE	YYBA Corp	4db609cc-f329-62a4-e063-6394a90aefc1	2026-03-23	Warnings	Exact identifier application number: M015
Topical Hemorrhoid Relief Gel	MENTHOL, UNSPECIFIED FORM	Yantai Aien Biotechnology Co., Ltd.	4d6e6667-ab1c-de7c-e063-6294a90a0b9b	2026-03-20	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	a23ded81-78ba-c199-a8f0-aaf360b216ff	18
1438497	cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository	SCD	a23ded81-78ba-c199-a8f0-aaf360b216ff	18
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	SY	a23ded81-78ba-c199-a8f0-aaf360b216ff	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-2880-31	00573288031	48 BLISTER PACK in 1 CARTON (0573-2880-31) > 1 SUPPOSITORY in 1 BLISTER PACK	48 blister pack	2004-01-05	0000-00-00	No	No	Current