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 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
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