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 14 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
application number: M015
Bunnies Bum Anorectal NumbingLIDOCAINEFloCal Distributors LLC3712e151-d171-1c5d-e063-6294a90a36c02025-06-08WarningsExact identifier
application number: M015
RECOVERY NumbingLIDOCAINE HCLRenu Laboratories, LLCe4e05cae-56a6-b2b3-e053-2a95a90a104b2025-06-06WarningsExact identifier
application number: M015
Hemorrohoid Master CreamLIDOCAINE, PHENYLEPHRINE HCLEbanel Laboratories, Inc.36eccc74-107e-3914-e063-6294a90a18562025-06-06WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc36c9988b-9e61-ebbf-e063-6394a90a41142025-06-04WarningsExact identifier
application number: M015
Hemorrhoid MasterLIDOCAINE, PHENYLEPHRINE HCLClinical Resolution Laboratory, Inc.36caf20d-116a-f86a-e063-6294a90a7b622025-06-04WarningsExact identifier
application number: M015
Quick NumbLIDOCAINEClinical Resolution Laboratory, Inc.351b95a6-e038-d9aa-e063-6294a90a41722025-05-29WarningsExact identifier
application number: M015
Dibucaine Topical Anesthetic 1% HemorrhoidalDIBUCAINERugby Laboratories Inc.f23c8cd1-98f9-41cd-84d4-cf01c2ede29a2025-05-29WarningsExact identifier
application number: M015
The Femme Fix Hemorrhoid TreatmentLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEPOPPY COLLECTIVE LLC5217b5d9-b835-4428-a6b3-e6b2556307422025-05-27WarningsExact identifier
application number: M015
MAXOCAINE Topical Anesthetic AnorectalLIDOCAINEPRIME COMMERCE, LLC26e8c867-8cb8-4a25-91b1-da45a1edd09a2025-05-27WarningsExact identifier
application number: M015
Numb25LIDOCAINEEbanel Laboratories, Inc.35107403-55ae-c627-e063-6394a90a0b5c2025-05-27WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc350e4d5e-dac7-ae4e-e063-6394a90a76b42025-05-27WarningsExact identifier
application number: M015
Numb25LIDOCAINE 5%Ebanel Laboratories, Inc350fd302-8fd5-5288-e063-6294a90aa3822025-05-27WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc35095bed-0e91-c44a-e063-6294a90add6e2025-05-27WarningsExact identifier
application number: M015
Numb520LIDOCAINEClinical Resolution Laboratory, Inc.a0411950-c6ee-4427-acb6-3cef58b0e93e2025-05-15WarningsExact identifier
application number: M015
Numb25LIDOCAINEClinical Resolution Laboratory, Inc.cfcb839d-47b4-4925-bb30-97b64d20d2b32025-05-15WarningsExact identifier
application number: M015
Numb520LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEClinical Resolution Laboratory, Inc.65d3b614-361d-4fb9-9583-a95be754bc822025-05-15WarningsExact identifier
application number: M015
ChamosynBARRIER CREAMLinks Medical Productsf9dfb2d7-4684-4525-994e-1e0ff90413d92025-05-08WarningsExact identifier
application number: M015
LANOZEM HEMORRHOIDALMENTHOL, PETROLATUMSod-e Biotech Ltd34901e83-8f24-8460-e063-6394a90a27442025-05-07WarningsExact identifier
application number: M015
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC96d2e0e7-2de0-4660-9ffd-9edb2ad224d82025-04-18WarningsExact 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