FDA.reportPublic FDA data

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
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039541Internal RxNorm lookup
1039550Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b848f53d-8aea-4efe-aa2c-009d5121fc33Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11509-5035-12020-04-21C16284748780-19d75b9d0-c0eb-f424-e053-dadaa90a57ceVagisil Medicated Anti-Itch Wipes Maximum Strength
11509-5035-12020-01-31C16284748780-19d75b9d0-c0eb-f424-e053-dadaa90a57ceVagisil Medicated Anti-Itch Wipes Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11509-5035-1VAGISIL Anti-Itch Medicated Wipes Maximum Strength4.5 g in 1 PACKETCLOTH4.59
11509-5035-1VAGISIL Anti-Itch Medicated Wipes Maximum Strength12 in 1 CARTONCLOTH129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11509-5035-1EA - Each11509-5035e1c44b32-37dc-49d1-b8c1-d95fe3bdc5e412022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
PRAMOXINEACTIVE MOIETY068X84E056VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XVAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
DISODIUM COCOAMPHODIACETATEINACTIVE INGREDIENT18L9G3U51MVAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KVAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
ETHYLPARABENINACTIVE INGREDIENT14255EXE39VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXVAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DVAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
PEG-7 GLYCERYL COCOATEINACTIVE INGREDIENTVNX7251543VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TVAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHVAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
TRIETHANOLAMINE COCOYL GLUTAMATEINACTIVE INGREDIENTLA19WH54ULVAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6
WATERINACTIVE INGREDIENT059QF0KO0RVAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11509-5035VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]9Current NDC, Legacy NDC, 2 package rows20241211_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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4dfc77bb-11dd-e0f0-e063-6294a90a4e9c2026-07-24WarningsExact identifier
application number: M017
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a5b47ce-2bf1-42c7-e063-6294a90af09f2026-07-23WarningsExact identifier
application number: M017
DERMFREE WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c63b3-44de-8736-e063-6394a90ac21a2026-07-23WarningsExact identifier
application number: M017
DERMFREE Anti-itchHYDROCORTISONE1% ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a5af4c6-555a-e74c-e063-6394a90aa6ce2026-07-23WarningsExact identifier
application number: M017
DERMFREE HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4a5d0e79-d620-0147-e063-6294a90a31032026-07-23WarningsExact identifier
application number: M017
MAG 5 PT WARMING FORMULAMENTHOLRENU LABORATORIES, LLCa499ac9b-0e8e-e23f-e053-2a95a90abe9a2026-07-23WarningsExact identifier
application number: M017
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
application number: M017
Numbing Pain ReliefLIDOCAINE 4%Walgreen Company2425badb-e196-e9f8-e063-6294a90a7bf42026-07-22WarningsExact identifier
application number: M017
Cooling Pain ReliefMENTHOL 4.5%Walgreen Company24345ccf-c96f-31b0-e063-6294a90a82b52026-07-22WarningsExact identifier
application number: M017
Heat Pain ReliefCAPSAICIN 0.1%Walgreen Company2434f9cf-74aa-17af-e063-6294a90a56d92026-07-22WarningsExact identifier
application number: M017
Pain Relief Patch LidocaineLIDOCAINEHyVee41c26a66-3371-2c2c-e063-6294a90aa38b2026-07-22WarningsExact identifier
application number: M017
CVS Ultra Strength MuscleMENTHOL, CAMPHOR, METHYL SALICYLATECVS Pharmacy48bef8bc-6e39-a328-e063-6394a90ae4502026-07-22WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative573c2d85-9e0b-7955-e063-6394a90aff642026-07-22WarningsExact identifier
application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
application number: M017
Bclsks NUMBINGMENTHOL 1% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e26770-ddf6-7515-e063-6394a90a4ab32026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039541pramoxine HCl 1 % Medicated PadPSNb848f53d-8aea-4efe-aa2c-009d5121fc339
1039550Vagisil 1 % Medicated PadPSNb848f53d-8aea-4efe-aa2c-009d5121fc339
1039550pramoxine hydrochloride 10 MG/ML Medicated Pad [Vagisil Wipes]SBDb848f53d-8aea-4efe-aa2c-009d5121fc339
1039541pramoxine hydrochloride 10 MG/ML Medicated PadSCDb848f53d-8aea-4efe-aa2c-009d5121fc339
1039541pramoxine hydrochloride 1 % Medicated PadSYb848f53d-8aea-4efe-aa2c-009d5121fc339
1039541pramoxine hydrochloride 1 % Medicated WipeSYb848f53d-8aea-4efe-aa2c-009d5121fc339
1039550Vagisil 1 % Medicated WipesSYb848f53d-8aea-4efe-aa2c-009d5121fc339
1039550Vagisil Wipes 10 MG/ML Medicated PadSYb848f53d-8aea-4efe-aa2c-009d5121fc339

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11509-5035-11150950350112 PACKET in 1 CARTON (11509-5035-1) / 4.5 g in 1 PACKET12 packet2005-06-280000-00-00NoNoCurrent