FDA.reportPublic FDA data

Terramed Just Think Comfort GynoCare BV Guard Intimate Wipes

Product NDC
83004-038
11-digit product format
830040038
Labeler code
83004
Product ID
83004-038_52ce5c59-14ad-89fc-e063-6394a90a1e87
Type
HUMAN OTC DRUG
Nonproprietary name
PRAMOXINE HYDROCHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Rida LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-14
Substance
PRAMOXINE HYDROCHLORIDE
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Terramed Just Think Comfort GynoCare BV Guard Intimate Wipes
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 g/100mL

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb29f156-37b8-400e-802b-3e2671cb7dc8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83004-038-01Terramed Just Think Comfort GynoCare BV Guard Intimate Wipes4 in 1 CARTONCLOTH41
83004-038-01Terramed Just Think Comfort GynoCare BV Guard Intimate Wipes48 in 1 PACKAGECLOTH481

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 11 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineMENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP006539c9-1982-d6de-e063-6294a90a1a5a2025-10-17WarningsExact identifier
application number: M015
Xesso Strawberry Rear Comfort Glide 4% LidocaineLIDOCAINEPremium Natural Cosmetics Incefba09fc-6dd7-0f73-e053-2995a90a628a2025-10-17WarningsExact identifier
application number: M015
medicated padsWITCH HAZELTARGET CORPORATIONacd0d99d-2a77-4227-bebb-c819f4a526662025-10-14WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.40b0e8d6-4686-960b-e063-6294a90a016e2025-10-09WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.40b452a3-76b7-2433-e063-6294a90ab6b42025-10-09WarningsExact identifier
application number: M015
EQUATE HEMORRHOID RELIEFLIDOCAIN 5%WALMART, INCd96e8152-e36e-22fc-e053-2995a90a8b2b2025-10-08WarningsExact identifier
application number: M015
Pramoxine Hydrochloride AnorectalPRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals39a16b66-b0e9-412f-8773-8dec0a1227e02025-10-02WarningsExact identifier
application number: M015
Doctor Butlers Hemorrhoid and Fissure External Pain FormulaLIDOCAINE 5%Beyond Health, P.A.d92f22a7-c0b5-d8b8-e053-2a95a90a23762025-09-30WarningsExact identifier
application number: M015
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)LIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.3ffc57c7-5bf4-cba8-e063-6394a90a322f2025-09-29WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
application number: M015
Medi-First BurnLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation44bb5f25-1114-4bb1-8bcf-40402594abc42025-09-09WarningsExact identifier
application number: M015
Dr. Care Numbing Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3e456af7-9726-d17e-e063-6394a90ab5602025-09-08WarningsExact identifier
application number: M015
Medi-first Ivy-Rid First AidBENZOCAINE AND BENZETHONIUM CHLORIDEUnifirst First Aid Corporation905c97ad-0bba-46b1-939c-f16fbdb028182025-09-08WarningsExact identifier
application number: M015
MediFirst BurnLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation9fa5b348-29c2-4cd0-a945-0486bd27f5e02025-09-08WarningsExact identifier
application number: M015
Medi-First BurnLIDOCAINE HCLUnifirst First Aid Corporationb3ebf104-cc51-0ef5-e053-2a95a90a25c92025-09-08WarningsExact identifier
application number: M015
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation4c2e2b91-d2f6-4e41-9a4c-ecabca9830e82025-09-08WarningsExact identifier
application number: M015
Pain ReliefANALGESIC MENTHOLUnifirst First Aid Corporation8162d22d-04c0-de07-e053-2991aa0a99752025-09-08WarningsExact identifier
application number: M015
Green Guard BurnLIDOCAINE HCLUnifirst First Aid Corporationb451e96f-fcba-6495-e053-2a95a90a2adf2025-09-08WarningsExact identifier
application number: M015
Lidochill(TM) GelLIDOCAINE HCL 4%, MENTHOL 1%PureTek Corporationd2a9aeb6-8a94-49e7-ab46-84403560b6c82025-09-08WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3e1892de-378b-d2d0-e063-6294a90ad7db2025-09-05WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039541pramoxine HCl 1 % Medicated PadPSNbb29f156-37b8-400e-802b-3e2671cb7dc81
1039541pramoxine hydrochloride 10 MG/ML Medicated PadSCDbb29f156-37b8-400e-802b-3e2671cb7dc81
1039541pramoxine hydrochloride 1 % Medicated PadSYbb29f156-37b8-400e-802b-3e2671cb7dc81
1039541pramoxine hydrochloride 1 % Medicated WipeSYbb29f156-37b8-400e-802b-3e2671cb7dc81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-038-01830040038014 PACKAGE in 1 CARTON (83004-038-01) / 48 PATCH in 1 PACKAGE / 4 mL in 1 PATCH4 package2026-01-14NoNoCurrent