VAGISIL Anti-Itch Medicated Wipes Maximum Strength

Product NDC: 11509-5035
11-digit product format: 115095035
Labeler code: 11509
Product ID: 11509-5035_d52bff6a-9386-4ff7-a2ff-bef4a6ad07f8
Type: HUMAN OTC DRUG
Nonproprietary name: pramoxine hydrochloride
Dosage form: CLOTH
Route: TOPICAL
Labeler: Combe Incorporated
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-06-28
Substance: PRAMOXINE HYDROCHLORIDE
Active strength: 10 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: VAGISIL Anti-Itch Medicated Wipes Maximum Strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1039541	Internal RxNorm lookup
1039550	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
b848f53d-8aea-4efe-aa2c-009d5121fc33	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11509-5035-1	2020-04-21	C162847	48780-1	9d75b9d0-c0eb-f424-e053-dadaa90a57ce	Vagisil Medicated Anti-Itch Wipes Maximum Strength
11509-5035-1	2020-01-31	C162847	48780-1	9d75b9d0-c0eb-f424-e053-dadaa90a57ce	Vagisil Medicated Anti-Itch Wipes Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11509-5035-1	VAGISIL Anti-Itch Medicated Wipes Maximum Strength	4.5 g in 1 PACKET	CLOTH	4.5		9
11509-5035-1	VAGISIL Anti-Itch Medicated Wipes Maximum Strength	12 in 1 CARTON	CLOTH	12		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11509-5035-1	EA - Each	11509-5035	e1c44b32-37dc-49d1-b8c1-d95fe3bdc5e4	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
PRAMOXINE	ACTIVE MOIETY	068X84E056	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
DISODIUM COCOAMPHODIACETATE	INACTIVE INGREDIENT	18L9G3U51M	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
PEG-7 GLYCERYL COCOATE	INACTIVE INGREDIENT	VNX7251543	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
TRIETHANOLAMINE COCOYL GLUTAMATE	INACTIVE INGREDIENT	LA19WH54UL	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11509-5035	VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]	9	Current NDC, Legacy NDC, 2 package rows	20241211_b848f53d-8aea-4efe-aa2c-009d5121fc33.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 133 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermachange Cold Therapy	MENTHOL	Private Label Beauty and Wellness	12ef7dd8-3da3-9c87-e063-6394a90ac924	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Arthritis Relief	TROLAMIN SALICYLATE	Private Beauty Label and Wellness	12dbfa50-1b97-f988-e063-6394a90a662c	2024-03-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	b0f4010c-995f-40e1-aa40-92760e697a61	2024-03-02	Warnings	Exact identifier application number: M017
Icy Hot Advanced Relief	CAMPHOR AND MENTHOL	Chattem, Inc.	9979ff36-415b-44e4-bb10-6bf682cd00f9	2024-03-01	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	5051b650-18a4-481e-a8d7-d41d4ae51efd	2024-02-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	2999fecb-cb15-4023-ade4-ab5822b094d5	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8	MENTHOL	Amish Origins Management, LLC	aaad56d5-6737-4edc-af0e-8e207695c0ec	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	b120404f-5a07-4182-bb50-d943418622da	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	437491ca-60ff-4508-b408-f97e7152f638	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	ffe15aed-ea90-4db8-aace-d691a81c05ae	2024-02-29	Warnings	Exact identifier application number: M017
LidoPro Patch	LIDOCAINE, MENTHOL, AND METHYL SALICYLATE	Advanced Rx Pharmacy of Tennessee, LLC	128d0ba9-bc9d-af16-e063-6394a90af5ef	2024-02-29	Warnings	Exact identifier application number: M017
Leader Roll-On Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	e86cba40-6b10-454d-98b3-6b547456eaad	2024-02-29	Warnings	Exact identifier application number: M017
Maximum Strength Scalp Itch Relief Anti-itch	HYDROCORTISONE	Rite Aid	55569563-fc38-4f97-8e74-9f96e3173384	2024-02-28	Warnings	Exact identifier application number: M017
Walgreens Eczema Relief	HYDROCORTISONE ACETATE	Walgreen Co.	4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c	2024-02-28	Warnings	Exact identifier application number: M017
meijer Cold Therapy Pain Relieving analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	fb163112-d84d-418d-a410-3214c0ee4b5a	2024-02-28	Warnings	Exact identifier application number: M017
SunBurnt PLUS	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	12128c75-015d-8a72-e063-6394a90ae00a	2024-02-23	Warnings	Exact identifier application number: M017
Kroger Analgesic Analgesic	LIDOCAINE HYDROCHLORIDE	THE KROGER CO	e6c5ead3-87d0-48ed-a4dc-86cf89ebb285	2024-02-22	Warnings	Exact identifier application number: M017
Rugby Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Bryant Ranch Prepack	fcf48536-224e-4a3d-9124-770031823972	2024-02-22	Warnings	Exact identifier application number: M017
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	8bc3956b-b82d-4ed3-8bc3-db0078466bbc	2024-02-22	Warnings	Exact identifier application number: M017
Promescent Delay Wipes	BENZOCAINE	Absorption	f0a5b6be-acc5-473c-9054-b9534e769db1	2024-02-20	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039541	pramoxine HCl 1 % Medicated Pad	PSN	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039550	Vagisil 1 % Medicated Pad	PSN	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039550	pramoxine hydrochloride 10 MG/ML Medicated Pad [Vagisil Wipes]	SBD	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039541	pramoxine hydrochloride 10 MG/ML Medicated Pad	SCD	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039541	pramoxine hydrochloride 1 % Medicated Pad	SY	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039541	pramoxine hydrochloride 1 % Medicated Wipe	SY	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039550	Vagisil 1 % Medicated Wipes	SY	b848f53d-8aea-4efe-aa2c-009d5121fc33	9
1039550	Vagisil Wipes 10 MG/ML Medicated Pad	SY	b848f53d-8aea-4efe-aa2c-009d5121fc33	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11509-5035-1	11509503501	12 PACKET in 1 CARTON (11509-5035-1) / 4.5 g in 1 PACKET	12 packet	2005-06-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vagisil Medicated Anti-Itch Wipes Maximum Strength	Combe Incorporated \| Combe Laboratories, Inc.	2024-12-12	HUMAN OTC DRUG LABEL	9