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 78 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine-Pain-Relief-PatchLIDOCAINE-PAIN-RELIEF-PATCHHenan Enokon Medical Instrument Co., Ltd.3ecfa867-50f6-d98a-e063-6394a90aefa02025-09-14WarningsExact identifier
application number: M017
Meijer Hydrocortsione CreamHYDROCORTSIONE CREAM 1%Meijer Distribution Inc.1cbddb7e-f2e3-0951-e063-6394a90a3d372025-09-12WarningsExact identifier
application number: M017
JO Prolonger with BenzocaineBENZOCAINECC Wellness LLCd955f612-1267-f1be-e053-2995a90a53452025-09-12WarningsExact identifier
application number: M017
JO for Him Prolonger with LidocaineLIDOCAINECC Wellness LLCb12dc6a3-142d-3219-e053-2995a90aead02025-09-12WarningsExact identifier
application number: M017
Walgreens Medicated Foot PowderMENTHOLDavion, Inc58e1e7f7-6284-411f-9765-0e63eabca0f32025-09-12WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEAmerisource Bergen614f1e56-891f-4620-be10-0c075a1dbc3f2025-09-11WarningsExact identifier
application number: M017
Industrial Itch and Pain ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATER & R Lotion, Inc236415fc-f923-4a82-b54a-ecaf666dd2e02025-09-11WarningsExact identifier
application number: M017
Eco Lips Menthol Medicated Lip BalmMENTHOLEco Lips, Inc.fc4c25d6-6109-dfd8-e053-6394a90a4e912025-09-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Encube Ethicals, Inc.d6f5c0df-6262-4704-bb24-430f66bb2ca82025-09-09WarningsExact identifier
application number: M017
Blue-Emu Lidocaine Pain Relief CreamLIDOCAINE CREAM 4%Kingsway Pharmaceuticals dba NFI, LLC592811f2-e21c-6a58-e053-2991aa0a69a92025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation282ed5ef-8c2a-4092-9d99-1a7eee7a39e32025-09-09WarningsExact identifier
application number: M017
LubeLife Climax Control DelayBENZOCAINECC Wellness LLCe1a98e6d-0c24-75b8-e053-2a95a90ad1362025-09-09WarningsExact identifier
application number: M017
Blue-Emu Maximum Pain ReliefTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLCc863351a-951b-4f7c-a9c0-4289d702054a2025-09-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.02a65b25-78b2-4e29-9484-40e2228fb3842025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporatione90df2e5-2ef4-47dd-bd74-be9cea6d9d852025-09-08WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation69d6645e-db3c-4dc0-a9a5-e2bc963e2f282025-09-08WarningsExact identifier
application number: M017
SupreH Arnica Bruise CreamSUPREH ARNICA REMEDY PLUS BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3e41fc0e-54c3-2622-e063-6294a90a13c92025-09-07WarningsExact identifier
application number: M017
MentholMENTHOLFlexiGo Inc3607c326-6db0-a2cd-e063-6394a90a9eb62025-09-06WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYOTHERAPY MENTHOL CreamPAIN RELIEF CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e08cc87-2385-0838-e063-6394a90abf9b2025-09-05WarningsExact identifier
application number: M017
TIDL CLINICAL CRYOTHERAPY MENTHOL CreamCLINICAL CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e090b98-1db7-4174-e063-6394a90aa5392025-09-05WarningsExact 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