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 26 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sabharwals	LIDOCAINE 4% GEL PATCH	Dr. Sabharwal's Wound Care	102399b6-5be9-ee5e-e063-6394a90a3198	2026-04-02	Warnings	Exact identifier application number: M017
TATTOO NUMBX NUMBING PAIN RELIEVING	LIDOCAINE HYDROCHLORIDE	Scyberco Ltd	ac8eac04-ed5b-4c8e-9f9b-54d160b74606	2026-04-02	Warnings	Exact identifier application number: M017
FifthPulse Hydrocortisone	HYDROCORTISONE	WeCare Products LLC	f1fcb045-4a15-431b-9617-67eae9f87fbd	2026-04-02	Warnings	Exact identifier application number: M017
ANIXIKE Cream	MENTHOL 5% CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	4e8510e6-c0c7-bf6b-e063-6294a90a3b00	2026-04-02	Warnings	Exact identifier application number: M017
RAPID RELIEF	0.025% CAPSAICIN PAIN PATCH	83569	4ed549e8-0062-fb03-e063-6294a90aac65	2026-04-02	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL AND ZINC ACETATE	CVS Pharmacy	7e921988-ec66-38dc-e053-2a91aa0a7346	2026-04-01	Warnings	Exact identifier application number: M017
The Best Numbing Cream	TBNC	The Best Numbing Cream LLC	4ca3923b-f586-0aaf-e063-6294a90a16c1	2026-03-31	Warnings	Exact identifier application number: M017
ChapStick Classic Medicated	EXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	42798a6c-2d7e-80f6-e063-6294a90a105f	2026-03-31	Warnings	Exact identifier application number: M017
Roll-On Pain Relief Liquid	LIDOCAINE HCL	HyVee Inc	4da6f6fb-b182-360f-e063-6294a90abdf3	2026-03-31	Warnings	Exact identifier application number: M017
Hand Sanitizer	ALCOHOL	ProStat First Aid	4e54aecb-190f-3866-e063-6294a90a810a	2026-03-31	Warnings	Exact identifier application number: M017
Burn Mist	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	c53ab9dd-351a-400b-b873-4f396e0af54d	2026-03-31	Warnings	Exact identifier application number: M017
Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving	LIDOCAINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	f7faddb2-5153-4fdd-a5ef-778182cef460	2026-03-31	Warnings	Exact identifier application number: M017
ZENOL COOL	METHYL SALICYLATE, L-MENTHOL	BA TRADE INC	4e5c45f4-88ce-3a13-e063-6394a90a2a09	2026-03-31	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	091451fb-e30a-0012-e063-6394a90a3ba8	2026-03-31	Warnings	Exact identifier application number: M017
Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and Mint	MENTHOL	Chattem, Inc.	b16ba9c2-23bf-4fdf-b44b-7abb9fec1911	2026-03-31	Warnings	Exact identifier application number: M017
DR.PABU NUMBING	LIDOCAINE 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4e3a3c6c-4821-76ea-e063-6294a90a8f96	2026-03-30	Warnings	Exact identifier application number: M017
Doctor Jiao Antifungal Cream	MICONAZOLE NITRATE	Jiangxi Haiwei Pharmaceutical Co., Ltd.	4e3b231e-0642-bf63-e063-6394a90a905b	2026-03-30	Warnings	Exact identifier application number: M017
CVS Muscle Balm and Roll-On	CAMPHOR, MENTHOL	CVS Pharmacy	4e40025a-070a-508e-e063-6394a90af5d7	2026-03-30	Warnings	Exact identifier application number: M017
REGENECARE HA	LIDOCAINE HCL	MPM Medical LLC	c3eec066-38e8-4617-b34d-2f72ffb7a324	2026-03-30	Warnings	Exact identifier application number: M017
Softlips Naturals Medicated Matcha Honey	CAMPHOR, MENTHOL	The Mentholatum Company	4e03a721-73f3-b2f2-e063-6394a90a44e6	2026-03-27	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