FDA.reportPublic FDA data

Pain Relieving Cream

Product NDC
84334-000
11-digit product format
843340000
Labeler code
84334
Product ID
84334-000_26473383-282d-fb10-e063-6394a90a5fa2
Type
HUMAN OTC DRUG
Nonproprietary name
camphor and menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
GOLDEN TIGER DISTRIBUTION L.L.C.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-12-02
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
3; 3 mg/100mL; mg/100mL
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
Pain Relieving Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL3 mg/100mL
CAMPHOR (SYNTHETIC)3 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
5TJD82A1ETInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26473383-282c-fb10-e063-6394a90a5fa2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84334-000-03Pain Relieving Cream473.17 mL in 1 BOTTLE, PUMPCREAM473.173
84334-000-04Pain Relieving Cream946.33 mL in 1 BOTTLE, PUMPCREAM946.333
84334-000-05Pain Relieving Cream3776 mL in 1 BOTTLECREAM37763
84334-000-24Pain Relieving Cream118.29 mL in 1 TUBECREAM118.293
84334-000-06Pain Relieving Cream88.7 mL in 1 BOTTLE, WITH APPLICATORCREAM88.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84334-000PAIN RELIEVING CREAM (CAMPHOR AND MENTHOL) CREAM [GOLDEN TIGER DISTRIBUTION L.L.C.]3Current NDC, 4 package rows20241109_1b6f929a-db65-8a02-e063-6394a90a8b59.zip
84334-000PAIN RELIEVING CREAM (CAMPHOR AND MENTHOL) CREAM [GOLDEN TIGER DISTRIBUTION L.L.C.]1Current NDC, 1 package rows20241109_26473383-282c-fb10-e063-6394a90a5fa2.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 101 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magsoothium CBD Cooling Roll on ReliefMENTHOLUbu/Elements, Inc.2cf05dcd-6a44-de08-e063-6394a90aaba02025-01-30WarningsExact identifier
application number: M017
Meijer Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMMeijer, Inc.dac73a07-7569-4788-977a-f10d098da75d2025-01-30WarningsExact identifier
application number: M017
ZCort UltraHYDROCORTISONE ACETATE 1%RxDino, LLCb68f8ada-58e8-e8e4-e053-2a95a90ab02d2025-01-29WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINE 4%Noble OTC LLC12a3ce63-6fce-0993-e063-6294a90a40d52025-01-28WarningsExact identifier
application number: M017
INTIMALE LIDOCAINE DELAYLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED5ddd7d56-bf51-462b-afcd-944861e497812025-01-28WarningsExact identifier
application number: M017
CBD Clinic Relax MassageCAMPHORABACUS HEALTH PRODUCTS, INC.f0eae24e-09cf-0d2d-e053-2a95a90acedc2025-01-28WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebbc0f-9888-b812-e053-2a95a90a5d3d2025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Arthritis Aches and Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec7255-bb36-41cd-e053-2a95a90aeac42025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Back and Neck Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec8fc9-c401-5f23-e053-2995a90acb1c2025-01-28WarningsExact identifier
application number: M017
Muscle TherapyMETHYL SALICYLATE, CAMPHOREverlaan Organics Inc0890a683-9a66-fdbd-e063-6294a90ae5262025-01-27WarningsExact identifier
application number: M017
Joint TherapyCAMPHOREverlaan Organics Inc08904b77-d6db-8b82-e063-6394a90ace4f2025-01-27WarningsExact identifier
application number: M017
Warrior Arthritis ReliefTROLAMIN SALICYLATE 10%Derma Care Research Labs, LLC013f48b9-913f-b283-e063-6394a90abd732025-01-27WarningsExact identifier
application number: M017
DCH Cool and HeatMENTHOL 16%Derma Care Research Labs, LLCff323282-612c-eaf8-e053-6394a90ab7792025-01-27WarningsExact identifier
application number: M017
GerigentleHYDROCORTISONEGERI-GENTLE CORPORATION0adfa2f0-9758-5c54-e063-6294a90a461f2025-01-25WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative Inc.42f1abeb-f6d7-01c3-e054-00144ff88e882025-01-23WarningsExact identifier
application number: M017
FORTHiQ Pain Relief Lidocaine PatchPAIN RELIEF LIDOCAINE PATCHHenan Enokon Medical Instrument Co., Ltd.2c593420-5788-3422-e063-6394a90a18902025-01-22WarningsExact identifier
application number: M017
RETALIEF LIDOCAINE 5LIDOCAINEReliable 1 Laboratories LLC2c262f3c-8cb2-4384-e063-6294a90a436d2025-01-20WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1c3e5068-dd61-ebdb-e063-6294a90a97cc2025-01-20WarningsExact identifier
application number: M017
PROHEAL BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab12025-01-19WarningsExact identifier
application number: M017
HERSTAT PLUS Cold Sore TreatmentCAMPHOR, MENTHOLHerstat (USA) Inc.e20ea714-663d-c4ac-e053-2a95a90a5ecc2025-01-18WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84334-000-0384334000003473.17 mL in 1 BOTTLE, PUMP (84334-000-03) 473.17 ml2004-12-02NoNoCurrent
84334-000-0484334000004946.33 mL in 1 BOTTLE, PUMP (84334-000-04) 946.33 ml2004-12-02NoNoCurrent
84334-000-05843340000053776 mL in 1 BOTTLE (84334-000-05) 3776 ml2004-12-02NoNoCurrent
84334-000-068433400000688.7 mL in 1 BOTTLE, WITH APPLICATOR (84334-000-06) 88.7 ml2004-12-02NoNoCurrent
84334-000-2484334000024118.29 mL in 1 TUBE (84334-000-24) 118.29 ml2004-12-02NoNoCurrent