Preparation H Cooling Gel

Product NDC: 0573-2840
Requested package NDC: 0573-2840-10
11-digit product format: 005732840
Labeler code: 0573
Product ID: 0573-2840_15581b30-e802-550a-e063-6394a90a3aae
Type: HUMAN OTC DRUG
Nonproprietary name: phenylephrine hcl, witch hazel
Dosage form: GEL
Route: TOPICAL
Labeler: Haleon US Holdings LLC
Application: M015
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-01-01
Substance: PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
Active strength: 2.5; 500 mg/g; mg/g
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

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0573-2840	0573-2840-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0573-2840	0573-2840-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0573-2840	0573-2840-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`

Additional Listing Data#

Finished product: Yes
Brand name base: Preparation H Cooling Gel
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/g
WITCH HAZEL	500 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup
101I4J0U34	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
249465	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
cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0573-2840-10	2022-12-14	Drug Facts
0573-2840-20	2022-12-14	Drug Facts
0573-2840-10	2022-01-28	Drug Facts
0573-2840-20	2022-01-28	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0573-2840-10	Preparation H Cooling Gel	26 g in 1 TUBE	GEL	26	9
0573-2840-10	Preparation H Cooling Gel	1 in 1 CARTON	GEL	1	9
0573-2840-20	Preparation H Cooling Gel	1 in 1 CARTON	GEL	1	9
0573-2840-20	Preparation H Cooling Gel	51 g in 1 TUBE	GEL	51	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-2840-10	GM - Gram	0573-2840	644c6680-7646-486f-8f54-c5a0059b4d79	1	2014-01-04
0573-2840-20	GM - Gram	0573-2840	96323852-5702-424d-99f5-98a7dc99da55	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
phenylephrine hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	PREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WYETH CONSUMER HEALTHCARE]	3
witch hazel	ACTIVE INGREDIENT	101I4J0U34	PREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WYETH CONSUMER HEALTHCARE]	3
phenylephrine	ACTIVE MOIETY	1WS297W6MV	PREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WYETH CONSUMER HEALTHCARE]	3
witch hazel	ACTIVE MOIETY	101I4J0U34	PREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WYETH CONSUMER HEALTHCARE]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-2840	PREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [HALEON US HOLDINGS LLC]	9	Current NDC, Legacy NDC, 4 package rows	20240406_cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4.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 1 of 22 · 425 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine Numbing Cream	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	5457b3d7-e6b6-34a7-e063-6394a90aa240	2026-08-03	Warnings	Exact identifier application number: M015
HEMORRHOIDALCREAMPROCURE	PHENYLEPHRINE HCL, PETROLATUM, MINERAL OIL	TWIN MED, LLC	e9c44756-1c98-41be-e053-2995a90a35b4	2026-08-03	Warnings	Exact identifier application number: M015
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	YYBA CORP	582a0001-da1e-909a-e063-6394a90a2b11	2026-08-03	Warnings	Exact identifier application number: M015
up and up	PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	b42775ae-44fe-487e-b9ca-21d9687020a9	2026-07-29	Warnings	Exact identifier application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	578fa642-ff30-e511-e063-6294a90a5987	2026-07-26	Warnings	Exact identifier application number: M015
CVS Topical Anesthetic Hemorrhoidal	DIBUCAINE	CVS PHARMACY, INC	9f3d4fdb-ad82-4ab8-8a9e-252d027068ab	2026-07-25	Warnings	Exact identifier application number: M015
Moisture Barrier	MENTHOL 0.44%, ZINC OXIDE 20.6%	Walgreen Company	258f3392-0f42-21e8-e063-6294a90ae9ad	2026-07-22	Warnings	Exact identifier application number: M015
RectaEase Hemorrhoid Relief Cream	LIDOCAINE	Trifecta Pharmaceuticals USA LLC	c054921a-9f1b-7c75-e053-2995a90a1738	2026-07-20	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	KORVIA GLOBAL Inc.	5690db03-4d62-9660-e063-6394a90a2fc0	2026-07-14	Warnings	Exact identifier application number: M015
Gembooxt Topical Numbing Cream	LIDOCAINE HCL	Guangdong Quadrant Ecological Technology Co., Ltd.	49951a3e-3b62-3d66-e063-6294a90a9360	2026-07-13	Warnings	Exact identifier application number: M015
Zmztuhua Numbing Cream	LIDOCAINE	Guangzhou Hechuang Commercial Service Co.,Ltd.	56417dc6-c14b-ad17-e063-6294a90af7e5	2026-07-10	Warnings	Exact identifier application number: M015
Tina Davies IceCream	LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	TINA DAVIES PROFESSIONAL LLC	6a2b3199-f405-4455-9a02-8885d24eef9c	2026-07-09	Warnings	Exact identifier application number: M015
Drs pharmacy HEMORRHOIDAL	PHENYLEPHRINE HCL, WITCH HAZEL	OL PHARMA TECH, LLC Drs PHARMACY	164169b9-0627-9d1a-e063-6294a90ac46d	2026-07-09	Warnings	Exact identifier application number: M015
CAREALL Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	New World Imports, Inc	561c601f-c2cd-f09c-e063-6294a90adb45	2026-07-08	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	H E B	09b814f4-86b5-4810-bf52-cc88396451c2	2026-07-07	Warnings, Adverse reactions	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	ADUSA Distribution, LLC	c50d0496-6f09-43c2-9383-3250885968c9	2026-06-29	Warnings, Adverse reactions	Exact identifier application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	55260a3e-637a-c53b-e063-6394a90a1b09	2026-06-27	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal	HEMORRHOIDAL RECTAL SUPPOSITORIES	Walgreens	20c41406-99b2-bc89-e063-6294a90aed73	2026-06-25	Warnings	Exact identifier application number: M015
CalaSoothe	CALAMINE, MENTHOL, AND ZINC OXIDE	Dynarex Corporation	54f12005-acfe-4821-e063-6394a90ac304	2026-06-24	Warnings	Exact identifier application number: M015
tina davies IceCream Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	TINA DAVIES PROFESSIONAL LLC	10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd	2026-06-24	Warnings	Exact identifier application number: M015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
101I4J0U34	WITCH HAZEL		WITCH HAZEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
249465	phenylephrine HCl 0.25 % / witch hazel 50 % Rectal Gel	PSN	cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4	9
249465	phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal Gel	SCD	cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4	9
249465	phenylephrine 0.25 % / witch hazel 50 % Rectal Gel	SY	cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-2840-10	00573284010	1 TUBE in 1 CARTON (0573-2840-10) / 26 g in 1 TUBE	1 tube	2004-01-01	0000-00-00	No	No	Current