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 18 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hemorrhoid Pain Relief	LIDOCAINE	Telebrands Corp	04164425-ca3b-ef24-e063-6294a90a59d8	2024-11-20	Warnings	Exact identifier application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic	LIDOCAINE	Telebrands Corp	f525075a-d7ee-dad0-e053-2a95a90a6f3f	2024-11-20	Warnings	Exact identifier application number: M015
Curist Lidocaine Numbing Relief	LIDOCAINE	Little Pharma, Inc.	bff3c422-a0df-6196-e053-2a95a90af033	2024-11-20	Warnings	Exact identifier application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinum	LIDOCAINE 5%	Telebrands Corp	2774ec41-7366-ac8c-e063-6394a90a1ee2	2024-11-20	Warnings	Exact identifier application number: M015
Walgreens Anorectal Lidocaine Cream	5% LIDOCAINE	Walgreens Company	3052fac7-fd68-43f4-9950-8c07288a6b6d	2024-11-20	Warnings	Exact identifier application number: M015
Lidocaine Anorectal	LIDOCAINE	Patrin Pharma, Inc	456d41fe-8449-4980-9291-d7a3b65a900d	2024-11-13	Warnings	Exact identifier application number: M015
MyDerm	PENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL,	Inspec Solution LLC.	2618eba1-9308-a666-e063-6394a90ac3d2	2024-11-04	Warnings	Exact identifier application number: M015
Granulotion Medicated	MENTHOL, ZINC OXIDE	GL HEALTH, INC.	01701780-b160-415b-b34d-362237179475	2024-10-29	Warnings	Exact identifier application number: M015
rexall hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Dolgencorp Inc	0415c51b-5a12-49d4-8968-0131ddb85545	2024-10-23	Warnings	Exact identifier application number: M015
Exchange Select Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Army & Air Force Exchange Service	8155ed74-9412-498f-998c-4a29c46e934f	2024-10-23	Warnings	Exact identifier application number: M015
Leader Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. dba Leader	c4814524-0f4c-4351-a431-5b4b6431fd28	2024-10-23	Warnings	Exact identifier application number: M015
basic care hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Amazon.com Services LLC	617d9213-31f0-4c71-be0c-7961b96e5143	2024-10-23	Warnings	Exact identifier application number: M015
Signature Care Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Safeway	e74b71a1-915d-4e5b-b548-d5cce7945dbd	2024-10-23	Warnings	Exact identifier application number: M015
Equaline Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	d29b7824-ff9e-4875-b3de-92721c8add0e	2024-10-23	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Publix Super Markets Inc	a241cb37-7007-4fd8-a12e-f3fc6d6f780e	2024-10-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Kroger Company	d44ca22a-dc20-454d-99aa-403a8c7a3e00	2024-10-22	Warnings	Exact identifier application number: M015
rugby hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Rugby Laboratories	c1a126b5-0d34-437f-a7ef-8d5cbeb7b03b	2024-10-22	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Meijer Distribution Inc	1431397e-3515-4794-a494-70667948e14c	2024-10-18	Warnings	Exact identifier application number: M015
signature care hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Safeway	afcf68cf-f187-44d3-ad91-b1e79b182bc6	2024-10-17	Warnings	Exact identifier application number: M015
hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	H E B	1435432d-5ff2-468b-808d-fb0c99a0717b	2024-10-17	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