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 11 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medline	MENTHOL, WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	006539c9-1982-d6de-e063-6294a90a1a5a	2025-10-17	Warnings	Exact identifier application number: M015
Xesso Strawberry Rear Comfort Glide 4% Lidocaine	LIDOCAINE	Premium Natural Cosmetics Inc	efba09fc-6dd7-0f73-e053-2995a90a628a	2025-10-17	Warnings	Exact identifier application number: M015
medicated pads	WITCH HAZEL	TARGET CORPORATION	acd0d99d-2a77-4227-bebb-c819f4a52666	2025-10-14	Warnings	Exact identifier application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	40b0e8d6-4686-960b-e063-6294a90a016e	2025-10-09	Warnings	Exact identifier application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	40b452a3-76b7-2433-e063-6294a90ab6b4	2025-10-09	Warnings	Exact identifier application number: M015
EQUATE HEMORRHOID RELIEF	LIDOCAIN 5%	WALMART, INC	d96e8152-e36e-22fc-e053-2995a90a8b2b	2025-10-08	Warnings	Exact identifier application number: M015
Pramoxine Hydrochloride Anorectal	PRAMOXINE HYDROCHLORIDE	Stratus Pharmaceuticals	39a16b66-b0e9-412f-8773-8dec0a1227e0	2025-10-02	Warnings	Exact identifier application number: M015
Doctor Butlers Hemorrhoid and Fissure External Pain Formula	LIDOCAINE 5%	Beyond Health, P.A.	d92f22a7-c0b5-d8b8-e053-2a95a90a2376	2025-09-30	Warnings	Exact identifier application number: M015
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	3ffc57c7-5bf4-cba8-e063-6394a90a322f	2025-09-29	Warnings	Exact identifier application number: M015
Hemorrhoidal Pain Relief	HEMORRHOIDAL PAIN RELIEF CREAM	Neilmed Pharmaceuticals Inc.	374dc1c0-4243-b272-e063-6394a90a5a6b	2025-09-24	Warnings	Exact identifier application number: M015
Medi-First Burn	LIDOCAINE HYDROCHLORIDE	Unifirst First Aid Corporation	44bb5f25-1114-4bb1-8bcf-40402594abc4	2025-09-09	Warnings	Exact identifier application number: M015
Dr. Care Numbing Cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	3e456af7-9726-d17e-e063-6394a90ab560	2025-09-08	Warnings	Exact identifier application number: M015
Medi-first Ivy-Rid First Aid	BENZOCAINE AND BENZETHONIUM CHLORIDE	Unifirst First Aid Corporation	905c97ad-0bba-46b1-939c-f16fbdb02818	2025-09-08	Warnings	Exact identifier application number: M015
MediFirst Burn	LIDOCAINE HYDROCHLORIDE	Unifirst First Aid Corporation	9fa5b348-29c2-4cd0-a945-0486bd27f5e0	2025-09-08	Warnings	Exact identifier application number: M015
Medi-First Burn	LIDOCAINE HCL	Unifirst First Aid Corporation	b3ebf104-cc51-0ef5-e053-2a95a90a25c9	2025-09-08	Warnings	Exact identifier application number: M015
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Unifirst First Aid Corporation	4c2e2b91-d2f6-4e41-9a4c-ecabca9830e8	2025-09-08	Warnings	Exact identifier application number: M015
Pain Relief	ANALGESIC MENTHOL	Unifirst First Aid Corporation	8162d22d-04c0-de07-e053-2991aa0a9975	2025-09-08	Warnings	Exact identifier application number: M015
Green Guard Burn	LIDOCAINE HCL	Unifirst First Aid Corporation	b451e96f-fcba-6495-e053-2a95a90a2adf	2025-09-08	Warnings	Exact identifier application number: M015
Lidochill(TM) Gel	LIDOCAINE HCL 4%, MENTHOL 1%	PureTek Corporation	d2a9aeb6-8a94-49e7-ab46-84403560b6c8	2025-09-08	Warnings	Exact identifier application number: M015
Signature numbing cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	3e1892de-378b-d2d0-e063-6294a90ad7db	2025-09-05	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