Preparation H

Product NDC: 0573-2884
11-digit product format: 005732884
Labeler code: 0573
Product ID: 0573-2884_155865d1-91f7-90d4-e063-6394a90a5945
Type: HUMAN OTC DRUG
Nonproprietary name: cocoa butter, phenylephrine hydrochloride, and witch hazel
Dosage form: KIT
Labeler: Haleon US Holdings LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-07-01
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 6 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 package	package	0573-2884-12	`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 package	package	0573-2884-12	`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 package	package	0573-2884-12	`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: Preparation H
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
844379	Internal RxNorm lookup
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
2f370875-0225-47b7-b43f-8fa4600d2a0e	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
0573-2884-12	2023-02-08	C162847	48780-1	d6a99b39-6597-a426-e053-dadaa90af4c2	Drug Facts
0573-2884-12	2022-01-28	C162847	48780-1	d6a99b39-6597-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0573-2884-12	Preparation H	1 in 1 CARTON	KIT	1		7

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, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
WITCH HAZEL	ACTIVE INGREDIENT	101I4J0U34	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
WITCH HAZEL	ACTIVE MOIETY	101I4J0U34	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
CAPRYL/CAPRAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	231H3ZT9NE	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
PROPYLENE GLYCOL, (R)-	INACTIVE INGREDIENT	602HN5L69H	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [PFIZER CONSUMER HEALTHCARE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-2884	PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE, AND WITCH HAZEL) KIT [HALEON US HOLDINGS LLC]	7	Current NDC, Legacy NDC, 1 package rows	20240406_2f370875-0225-47b7-b43f-8fa4600d2a0e.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

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	2f370875-0225-47b7-b43f-8fa4600d2a0e	7
844379	witch hazel 50 % Medicated Pad	PSN	2f370875-0225-47b7-b43f-8fa4600d2a0e	7
1438497	cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository	SCD	2f370875-0225-47b7-b43f-8fa4600d2a0e	7
844379	witch hazel 500 MG/ML Medicated Pad	SCD	2f370875-0225-47b7-b43f-8fa4600d2a0e	7
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	SY	2f370875-0225-47b7-b43f-8fa4600d2a0e	7
844379	witch hazel 50 % Medicated Pad	SY	2f370875-0225-47b7-b43f-8fa4600d2a0e	7
844379	witch hazel 50 % Medicated Wipes	SY	2f370875-0225-47b7-b43f-8fa4600d2a0e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-2884-12	00573288412	1 KIT in 1 CARTON (0573-2884-12) * 12 SUPPOSITORY in 1 BLISTER PACK * 4 CLOTH in 1 APPLICATOR	1 kit	2015-07-01	0000-00-00	No	No	Current