Preparation H Cooling Gel

Product NDC: 0573-2840
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 · 9 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	0573-2840-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0573-2840-20	`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	0573-2840-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0573-2840-20	`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	0573-2840-10	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0573-2840-20	`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 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 4 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEMORRHOIDAL	MINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY, INC	93482a9b-145b-42d4-96db-599c281a39f1	2026-06-10	Warnings	Exact identifier application number: M015
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	53f11395-f460-943f-e063-6294a90affef	2026-06-10	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Hemorrhoidal Wipes	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Rida LLC	f6ad00e7-c7b8-40b8-80c2-6e6bf85098b3	2026-06-08	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	CVS Pharmacy, Inc.	50f920da-b41a-480d-b3a0-df940caaee2d	2026-06-08	Warnings, Adverse reactions	Exact identifier application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	5356cf53-935d-a02f-e063-6394a90a6e5a	2026-06-05	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	HyVee Inc	b867f691-7a13-4659-b664-06aa36899310	2026-06-03	Warnings	Exact identifier application number: M015
Healcome Lidocaine Numbing Cream	LIDOCAINE	YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD	9b4eac02-1b1f-4630-92b4-b1d8c21abab5	2026-05-29	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomile	TOLNAFTATE	Rida LLC	5517c43f-03b2-499a-a217-d9cba3fb9fd2	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Citrus	TOLNAFTATE	Rida LLC	b4c5da66-5928-4352-ab90-fd46039e7955	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort GynoCare BV Guard Intimate Wipes	PRAMOXINE HYDROCHLORIDE	Rida LLC	bb29f156-37b8-400e-802b-3e2671cb7dc8	2026-05-27	Warnings	Exact identifier application number: M015
myDerm MEDICAL NEW Soothing Hemorrhoidal	WITCH HAZEL PENYLEPHRINE LIDOCAINE	Inspec Solutions	2ff42501-7730-42de-99dd-6fc53bbdf25f	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool Menthol	TOLNAFTATE	Rida LLC	8b15cb3b-f7cb-4a80-94b2-eeeafc9794e8	2026-05-27	Warnings	Exact identifier application number: M015
Lidocaine Roll-on	LIDOCAINE	YYBA Corp	52d060df-2095-dd68-e063-6394a90a7740	2026-05-27	Warnings	Exact identifier application number: M015
PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) Cream	LIDOCAINE 5% NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	52a25b97-7721-6410-e063-6394a90a228f	2026-05-25	Warnings	Exact identifier application number: M015
Arlun LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5241c26b-6c91-65a5-e063-6394a90a2477	2026-05-20	Warnings	Exact identifier application number: M015
tuiwaro LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5223b7fe-6aba-c77b-e063-6394a90ad27b	2026-05-18	Warnings	Exact identifier application number: M015
HEMORRHOIDAL WITH LIDOCAINE	GLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUM	CVS PHARMACY, INC	4d870c68-9e72-464e-b0b8-900d0d661e43	2026-05-14	Warnings	Exact identifier application number: M015
Oxify	LIDOCAINE 5%	Weeks & Leo Compnay, INC.	51cd58f7-c1c9-f4e2-e063-6294a90ad970	2026-05-14	Warnings	Exact identifier application number: M015
Lidocaine anorectal cream	LIDOCAINE 5%	EveryMarket Inc	1604daec-812f-4684-ba98-fbcda07a7461	2026-05-12	Warnings	Exact identifier application number: M015
PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES	WITCH HAZEL	Haleon US Holdings LLC	485437a8-b2e9-4acf-a20e-edb1f08a9cae	2026-05-11	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
0573-2840-20	00573284020	1 TUBE in 1 CARTON (0573-2840-20) / 51 g in 1 TUBE	1 tube	2004-01-01	0000-00-00	No	No	Current