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 54 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate hydrocortisoneHYDROCORTISONEWal-Mart Stores Inc70f4636d-4137-498b-ab81-0330de883e532025-12-15WarningsExact identifier
application number: M017
SALONPAS-HOT CAPSICUMCAPSAICINHisamitsu Pharmaceutical Co., Inc.ef5373aa-9857-4d01-95af-2d7716e54ae42025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLCf70a442e-7ba7-4860-e053-6394a90ac2bd2025-12-15WarningsExact identifier
application number: M017
Burn Ease, 3.5gBURN EASE, 3.5GProStat First Aid LLC004aa18f-3a97-f454-e063-6394a90afcff2025-12-15WarningsExact identifier
application number: M017
PS-3866 Burn Ease, 0.9gPS-3866 BURN EASE, 0.9GProStat First Aid LLC004d00a5-9cff-29ff-e063-6294a90aeb8c2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLC0037a1a4-d747-2567-e063-6394a90a721c2025-12-15WarningsExact identifier
application number: M017
PS-3885 Burn Ease, 3.5gPS-3885 BURN EASE, 3.5GProStat First Aid LLC004c6deb-2844-a0d0-e063-6394a90ae5e42025-12-15WarningsExact identifier
application number: M017
2677 First Aid Burn Cream2677 FIRST AID BURN CREAMProStat First Aid LLCff5bb628-8ef7-4540-e053-6394a90a55ed2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71b98b4-22d0-0124-e053-6394a90ae4cf2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71eb4f5-2280-5867-e053-6394a90aac572025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8e6842-c889-d5d3-e063-6394a90af8802025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8c59fb-3622-2bb7-e063-6294a90adc6e2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEFront Line Safety0e34cb09-d8c6-f8c0-e063-6294a90a0be02025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f52021f-af8a-5b95-e063-6294a90a2c2a2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLC0e25c936-e40a-e23c-e063-6294a90ac0e42025-12-15WarningsExact identifier
application number: M017
Sting Relief WipesSTING RELIEF WIPESProStat First Aid LLC0e20252a-5ecb-2526-e063-6294a90a8cde2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMFront Line Safety0f4ce2c2-f306-d95f-e063-6394a90ae7b32025-12-15WarningsExact identifier
application number: M017
Magsoothium BodyMENTHOL, CAPSAICINUbu/Elements, Inc.f604d30c-b17c-ec01-e053-2a95a90aa3042025-12-15WarningsExact identifier
application number: M017
Salonpas pain relieving JETMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.dd1ea3bf-891a-402e-8f43-14302bc9c3e52025-12-15WarningsExact identifier
application number: M017
Herbal Tendon Bone ReliefCAMPHOR MINTGuchutang Biotechnology (Longyan) Co., Ltd.45cf4040-9751-d24b-e063-6294a90aff272025-12-13WarningsExact 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