FDA.reportPublic FDA data

Gold Bond Intensive Relief Anti-Itch

Product NDC
41167-0507
11-digit product format
411670507
Labeler code
41167
Product ID
41167-0507_081ef785-fe00-4339-8aa6-c93b44f076e8
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine Hydrochloride, Menthol
Dosage form
LOTION
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-26
Substance
PRAMOXINE HYDROCHLORIDE; MENTHOL
Active strength
1; .5 g/100g; g/100g
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
Gold Bond Intensive Relief Anti-Itch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 g/100g
MENTHOL.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293905Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
41167-0507-0Gold Bond Intensive Relief Anti-Itch155 g in 1 BOTTLELOTION1554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0507GOLD BOND INTENSIVE RELIEF ANTI-ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) LOTION [CHATTEM, INC.]3Current NDC, Legacy NDC, 1 package rows20231101_e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f8.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 11 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OWELL NATURALS NEUROPATHY MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC56b8d0cc-2f35-7d38-e063-6294a90ad06d2026-07-16WarningsExact identifier
application number: M017
ANTIPHLAMINEL-MENTHOL, L-CAMPHOR, METHYL SALICYLATEMasaem Company56b93c89-295b-f33a-e063-6294a90a5fe42026-07-16WarningsExact identifier
application number: M017
Meriwether Skin Pain ReliefMENTHOL, UNSPECIFIED FORMMeriwether Skin LLCf6e155be-5879-4176-bb0e-e364f2e5cdf92026-07-16WarningsExact identifier
application number: M017
Medi-First Muscle Rub CreamMENTHOL, METHYL SALICYLATEUnifirst First Aid Corporation56a6b8b2-7ab0-9854-e063-6294a90ab5ba2026-07-15WarningsExact identifier
application number: M017
Painsil Pain Relief Roll-OnLIDOCAINE HYDROCHLORIDEPainsil LLCdee39dff-5749-4ef2-a9ed-182f25e01f672026-07-14WarningsExact identifier
application number: M017
VARICOSE VEINS MAXIMUM STRENGTHMENTHOLOWELL NATURAL & LLC5692914f-1b14-e3e3-e063-6394a90a94bf2026-07-14WarningsExact identifier
application number: M017
ZyloReliefLIDOCAINE HYDROCHLORIDEHighmark Pharma LLC635f5b98-f74c-495f-a537-686fcba9ccad2026-07-14WarningsExact identifier
application number: M017
ENOKON PAIN RELIEF Spray.PAIN RELIEF SPRAY.Henan Enokon Medical Instrument Co., Ltd.5675ec21-b947-2206-e063-6294a90aa5092026-07-12WarningsExact identifier
application number: M017
Topcare Pain Relief PatchPAIN RELIEF PATCH MEDICATED 5% MENTHOL761624f00d0b8-d2f4-843b-e063-6294a90a332b2026-07-12WarningsExact identifier
application number: M017
Penetral Roll-onCAPSAICIN 0.025%PureTek Corporation56204c03-8b15-a8b5-e063-6394a90a81892026-07-10WarningsExact identifier
application number: M017
Intensive Healing Itch ReliefITCH RELIEF CREAMNeilMed Pharmaceuticals Inc563ef1d5-2180-bc45-e063-6294a90a813d2026-07-10WarningsExact identifier
application number: M017
AVON Foot Works Arthritis Achy Foot and MuscleMETHYL SALICYLATECOSMAX USA, CORPORATION56440d3f-bc93-cebb-e063-6294a90a5f792026-07-10WarningsExact identifier
application number: M017
CHEONG KUN PAIN RELIEVINGCAMPHORCHEONG KUN PAIN RELIEVER OIL CHINESE MEDICINE FACTORY (MACAU) LIMITED557d5cb3-2a05-4f45-e063-6394a90a9b122026-07-10WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOLReckitt Benckiser LLC485c8208-c93b-5b84-e063-6394a90ab77a2026-07-10WarningsExact identifier
application number: M017
Fit Mist Pain ReliefMENTHOLAroma Sensations Incf5a98544-8bd7-42dc-a594-5559e3920e292026-07-09WarningsExact identifier
application number: M017
Nuturna SciaticaMENTHOLMicelle Laboratories, Incorporatedff200864-bedf-4138-bdec-2b23701406dd2026-07-09WarningsExact identifier
application number: M017
Lidocaine creamDRS LIDOCAINE 5% CREAMOL PHARMA TECH LLC. (Drs. Pharmacy)372fe018-1e5a-9ec4-e063-6294a90a15002026-07-09WarningsExact identifier
application number: M017
Nupharmisto 4% Lidocaine Numbing creamLIDOCAINE 4%EveryMarket Inc5615e49d-e03b-f915-e063-6294a90a17862026-07-08WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc561cc103-ae88-8f30-e063-6294a90a05c42026-07-08WarningsExact identifier
application number: M017
HealthWise Medicated Cold HotMENTHOLVeridian Healthcare, LLC561e1409-d1d8-e35d-e063-6394a90a4d8f2026-07-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293905menthol 0.5 % / pramoxine HCl 1 % Topical LotionPSNe5a3f8d4-b3d8-4b88-b9a9-833406d3e6f84
1293905menthol 5 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCDe5a3f8d4-b3d8-4b88-b9a9-833406d3e6f84
1293905menthol 0.5 % / pramoxine hydrochloride 1 % Topical LotionSYe5a3f8d4-b3d8-4b88-b9a9-833406d3e6f84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0507-041167050700155 g in 1 BOTTLE (41167-0507-0) 155 g2016-04-260000-00-00NoNoCurrent