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 22 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family wellness	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	FRONT PHARMACEUTICAL PLC	cfdd61e3-e12e-491c-b2a8-90fae19e8870	2023-10-27	Warnings	Exact identifier application number: M015
Family Wellness	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUM	FRONT PHARMACEUTICAL PLC	eb1785f4-5876-443b-b175-9b59d65d1a48	2023-10-26	Warnings	Exact identifier application number: M015
CVS Health Hemorrhoidal Cream	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	FRONT PHARMACEUTICAL PLC	cb448d78-553c-4e65-80c5-d4b31d7b3661	2023-10-26	Warnings	Exact identifier application number: M015
Family Wellness	PHENYLEPHRINE HCL, PETROLATUM, MINERAL	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bfa195d7-d87f-43b5-bbf1-7ec3a451de05	2023-10-25	Warnings	Exact identifier application number: M015
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots	LIDOCAINE	CVS PHARMACY, INC	82aa128a-44cd-4907-b0f7-8a31e086d3e6	2023-10-25	Warnings	Exact identifier application number: M015
TheraPlus Plus	PHENYLEPHRINE HCI	Zhejiang Jingwei Pharmaceutical Co., Ltd.	edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d	2023-10-25	Warnings	Exact identifier application number: M015
Assured Bikini Smooth Cream	LIDOCAINE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fb9ddde3-3f40-467e-8aff-26570144f0fc	2023-10-25	Warnings	Exact identifier application number: M015
Hemorrhoidal Cream	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM	Cardinal Health 110, LLC. dba Leader	85a51d5c-679e-1959-e053-2a91aa0a76d5	2023-10-25	Warnings	Exact identifier application number: M015
Family Wellness	GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fde9cd90-d63c-4058-b46e-511fecea36ec	2023-10-24	Warnings	Exact identifier application number: M015
Lidocaine 5%	LIDOCAINE	Apnar Pharma LP	ceedce20-5723-5a9a-e053-2a95a90a17a1	2023-10-21	Warnings	Exact identifier application number: M015
Numquick Topical Analgesic	EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE	Unit Dose, Ltd.	3f64cbd3-6745-4397-9767-3adc3b301e0e	2023-10-19	Warnings	Exact identifier application number: M015
Healquick Tattoo Balm	PETROLATUM	Unit Dose, Ltd.	96f92c82-a79a-4d7e-ba0c-5ea67e2b6e86	2023-10-19	Warnings	Exact identifier application number: M015
Numpot Topical Anesthetic	LIDOCAINE, PETROLATUM	Unit Dose, Ltd.	9143b50b-7d76-4545-aa2e-1bb77ffb44ae	2023-10-19	Warnings	Exact identifier application number: M015
Microcaine Topical Analgesic	LIDOCAINE	Unit Dose, Ltd.	5e8fa8b5-0524-4201-91e1-83e59a8f0415	2023-10-19	Warnings	Exact identifier application number: M015
Numstick	PETROLATUM, LIDOCAINE	Unit Dose, Ltd.	127bbd87-5402-4da2-abf3-dac6367735ec	2023-10-18	Warnings	Exact identifier application number: M015
ADVANCED NUMB Topical Anesthetic	LIDOCAINE HYDROCHLORIDE	Uber Scientific, LLC	859d1cad-badf-4c42-9b08-daacb3fae8b4	2023-10-13	Warnings	Exact identifier application number: M015
Hemorrhoidal Pain Relief with Aloe and VitaminE	HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE	NeilMed pharmaceuticals Inc.	076b5021-8ba0-0204-e063-6294a90a3337	2023-10-11	Warnings	Exact identifier application number: M015
Zensa Numbing Gel	LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%	Alera Skin Care Products Inc.	065a6eec-3896-0da8-e063-6394a90a849d	2023-09-27	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