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 10 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pranicura 5	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Pranicura Products LLC	af520a58-3f3c-4d28-a41f-3ed8f74da095	2025-11-04	Warnings	Exact identifier application number: M015
ProCure ClamaPlex	ZINC OXIDE 20.625, MENTHOL 0.44, WHITE PETROLATUM 66.335	Twin Med LLC	3d366857-5178-9032-e063-6294a90a40f3	2025-11-01	Warnings	Exact identifier application number: M015
GNP Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCL	Amerisource Bergen	b0f0ef97-9add-717f-e053-2a95a90a0eb0	2025-10-30	Warnings	Exact identifier application number: M015
REMEDY Calazime Skin Protectant	CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	1295cfcc-5b61-481b-964b-f53ffd0cb58e	2025-10-30	Warnings	Exact identifier application number: M015
Hemorrhoid Anesthetic	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Universal Distribution Center LLC	186c2d32-e8c5-d13d-e063-6294a90a2b0e	2025-10-30	Warnings	Exact identifier application number: M015
Workvie	LIDOCAINE HCL, MENTHOL	Marketites LLC	aebaffb5-58dd-ebd5-e053-2a95a90a14ed	2025-10-29	Warnings	Exact identifier application number: M015
hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	Publix Super Markets Inc	354a640c-bc7e-45c8-9df0-8b5b01767f5c	2025-10-29	Warnings	Exact identifier application number: M015
Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Pharmacy Value Alliance LLC	903b77fc-02bf-73b6-e053-2a95a90ad4cc	2025-10-24	Warnings	Exact identifier application number: M015
Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	CVS Pharmacy	845fc11b-707d-2027-e053-2991aa0a1c8a	2025-10-24	Warnings	Exact identifier application number: M015
Calmol 4	ZINC OXIDE AND COCOA BUTTER	Resical Inc.	5516f800-d3fa-4b90-a3eb-c0bdf3183b9b	2025-10-24	Warnings	Exact identifier application number: M015
Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HCL	Amerisourcebergen Drug Corporation	231a850a-bad6-9a30-e063-6394a90a0fdc	2025-10-24	Warnings	Exact identifier application number: M015
Signature Care Hemorrhoidal Cream (with applicator)	PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUM	BETTER LIVING BRANDS, LLC	b026a386-5e38-52ed-e053-2a95a90a6b0e	2025-10-24	Warnings	Exact identifier application number: M015
Americaine	BENZOCAINE	Insight Pharmaceuticals LLC	d13c022f-2f91-40b4-bd66-0cfc0e147a5f	2025-10-23	Warnings	Exact identifier application number: M015
Winco Hemorrhoidal	MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE	Winco Foods, LLC	04ca3ef1-fc6b-4683-b236-a75afc031fb5	2025-10-23	Warnings	Exact identifier application number: M015
Signature Care Medicated Cooling	WITCH HAZEL	Better Living Brands, LLC	b35dc719-a5a2-4839-870d-25313d3f7c9b	2025-10-22	Warnings	Exact identifier application number: M015
Family Care Hemorrhoidal	MINERAL OIL	United Exchange Corp	04375257-f4f3-48c3-a338-de43298b95eb	2025-10-22	Warnings	Exact identifier application number: M015
Family Wellness Hemorrhoidal	MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCL	Family Dollar Services, Inc	fe3293bc-80b5-b60a-e053-6394a90a4ede	2025-10-22	Warnings	Exact identifier application number: M015
Xesso Rear Comfort Glide	LIDOCAINE	PREMIUM NATURAL COSMETICS INC	e9eb262e-a1c1-7d5c-e053-2a95a90a7c9f	2025-10-22	Warnings	Exact identifier application number: M015
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangzhou Haishi Biological Technology Co., Ltd.	41a6d309-2722-1738-e063-6294a90a8a70	2025-10-21	Warnings	Exact identifier application number: M015
DERMOSCRIBE ICHYBUM	HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE	DERMOSCRIBE PTY LTD	134a88a1-13e5-4da0-8270-c380b57aaeb7	2025-10-17	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