FDA.reportPublic FDA data

Pain Relieving Cream

Product NDC
84338-001
11-digit product format
843380001
Labeler code
84338
Product ID
84338-001_2fb7560c-6512-6b79-e063-6394a90a5e24
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor and Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
PAIN WIZARD LIMITED LIABILITY COMPANY
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-12-02
Substance
CAMPHOR (SYNTHETIC); MENTHOL
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
CAMPHOR (SYNTHETIC)3 mg/100mL
MENTHOL3 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1cd37b69-2cfb-130d-e063-6394a90af50bAvailable 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
84338-001-16Pain Relieving Cream236 mL in 1 TUBECREAM2364
84338-001-23Pain Relieving Cream473.17 mL in 1 BOTTLE, PUMPCREAM473.174
84338-001-30Pain Relieving Cream59.14 mL in 1 TUBECREAM59.144
84338-001-92Pain Relieving Cream118.29 mL in 1 TUBECREAM118.294
84338-001-09Pain Relieving Cream88.7 mL in 1 BOTTLE, WITH APPLICATORCREAM88.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84338-001PAIN RELIEVING CREAM (CAMPHOR AND MENTHOL) CREAM [PAIN WIZARD LIMITED LIABILITY COMPANY]4Current NDC, 4 package rows20250309_1cd37b69-2cfb-130d-e063-6394a90af50b.zip
84338-001PAIN RELIEVING CREAM (CAMPHOR AND MENTHOL) CREAM [PAIN WIZARD LIMITED LIABILITY COMPANY]1Current NDC, 1 package rows20241109_2647bba1-87f4-3c16-e063-6394a90ae0c9.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 7 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cortizone 10 Itch Relief Massaging RollerballHYDROCORTISONEChattem, Inc.1e27682c-f856-41f1-9935-37540960a4c72026-07-31WarningsExact identifier
application number: M017
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsExact identifier
application number: M017
ACOLYE Lidocaine Cream Topical Analgesia CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd57deebf7-52f1-4256-e063-6294a90a75d52026-07-30WarningsExact identifier
application number: M017
Icy Hot Performance No-Mess Pain Relief CreamMENTHOL 16%, CAMPHOR 11%Chattem, Inc.5e3e272a-c001-4f57-9535-521ccc85ae652026-07-30WarningsExact identifier
application number: M017
Auixudin Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.57bc7b9e-e2f7-724b-e063-6394a90ab36f2026-07-29WarningsExact identifier
application number: M017
Jinfahe Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.57bcd9c5-767e-b634-e063-6394a90a28782026-07-29WarningsExact identifier
application number: M017
Maximun Strength Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLMeijer Distribution Incd0468514-58ea-4d8f-b634-a65bf95c03162026-07-29WarningsExact identifier
application number: M017
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.57ca9220-2778-790a-e063-6294a90af5062026-07-29WarningsExact identifier
application number: M017
Aspercreme Lidocaine No-Mess plus LavenderLIDOCAINE HCLChattem, Inc.3948a3d2-ce04-4703-8709-211e75c9c38d2026-07-29WarningsExact identifier
application number: M017
Aspercreme Professional CreamLIDOCAINE HCL 4%Chattem, Inc.ef297864-5917-4645-8ec7-f2bc49e037e82026-07-29WarningsExact identifier
application number: M017
LidoProLIDOCAINE AND MENTHOLClinic Pharmacdfd6b39-b430-4e95-a0f7-682cf3d78b522026-07-28WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHClinic Pharma2b4d2105-b7ad-2695-e063-6394a90a999b2026-07-28WarningsExact identifier
application number: M017
HEMPE Ice Muscle and Joint GelMENTHOLHealthcare International Research Limited57aec922-1de4-c579-e063-6394a90af6c82026-07-28WarningsExact identifier
application number: M017
Earths Care Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEDLC Laboratories, Inc.5c3976da-a6cb-4b94-ae41-3e86b1ab13cb2026-07-28WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Preferred Pharmaceuticals Inc.9e7568b6-52ae-4f7a-9bfd-503fd80a297e2026-07-28WarningsExact identifier
application number: M017
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsExact identifier
application number: M017
KENS PAIN AND ARTHRITIS FORMULAMENTHOLEezaway Relief Inc35834473-3ad5-41ec-a110-e742aa7e2ee42026-07-28WarningsExact identifier
application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal CreamLIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57935b64-6e2e-85d0-e063-6394a90a74282026-07-27WarningsExact identifier
application number: M017
1% Hydrocortisone Anti-itch1% HYDROCORTISONE ANTI-ITCHALAINA HEALTHCARE PRIVATE LIMITEDb8416467-55f7-4e5f-a5cb-3abd3e2bb5772026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTHMENTHOLOWELL NATURAL 8 LLC57984bc2-bf1d-c423-e063-6394a90a06ae2026-07-27WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84338-001-098433800010988.7 mL in 1 BOTTLE, WITH APPLICATOR (84338-001-09) 88.7 ml2004-12-02NoNoCurrent
84338-001-1684338000116236 mL in 1 TUBE (84338-001-16) 236 ml2004-12-02NoNoCurrent
84338-001-2384338000123473.17 mL in 1 BOTTLE, PUMP (84338-001-23) 473.17 ml2004-12-02NoNoCurrent
84338-001-308433800013059.14 mL in 1 TUBE (84338-001-30) 59.14 ml2025-03-03NoNoCurrent
84338-001-9284338000192118.29 mL in 1 TUBE (84338-001-92) 118.29 ml2004-12-02NoNoCurrent