FDA.reportPublic FDA data

CALMADOL

Product NDC
48201-004
11-digit product format
482010004
Labeler code
48201
Product ID
48201-004_42406bd7-6d6c-1f54-e063-6394a90a023e
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl Salicylate
Dosage form
LINIMENT
Route
TOPICAL
Labeler
GRANDALL DISTRIBUTING, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-08
Substance
CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE
Active strength
6; 1.9; 10 g/100g; g/100g; g/100g
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
CALMADOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)6 g/100g
MENTHOL1.9 g/100g
METHYL SALICYLATE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2688458Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31b7f84e-8b66-4d31-8e9c-279d0af2fe64Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48201-004-17CALMADOL1 in 1 BOXLINIMENT111
48201-004-17CALMADOL170.1 g in 1 JARLINIMENT170.111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48201-004CALMADOL (CAMPHOR, MENTHOL, METHYL SALICYLATE) LINIMENT [GRANDALL DISTRIBUTING, LLC]10Current NDC, Legacy NDC, 2 package rows20250510_31b7f84e-8b66-4d31-8e9c-279d0af2fe64.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 94 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Lidocaine BackLIDOCAINEWalgreen Co.e6bfd342-c0db-46b9-b5e6-5acbd860adf12025-04-25WarningsExact identifier
application number: M017
Electrum Numb FoamLIDOCAINE HCIRENU LABORATORIES, LLCc8472932-28b7-9189-e053-2a95a90a44df2025-04-25WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC66a2fd60-1757-45cc-a195-ecb9241dca2a2025-04-24WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Zanming Trading Co., Ltd.3385cddb-609f-62e8-e063-6294a90add812025-04-24WarningsExact identifier
application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEEDLIDOCAINE, MENTHOLCompass Health Brands Corp.2bd8aae0-2606-c7f2-e063-6294a90a9a202025-04-22WarningsExact identifier
application number: M017
Mqforu Pain PatchPAIN PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.1f878abd-54cd-1963-e063-6294a90a18842025-04-22WarningsExact identifier
application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED ROLL ONLIDOCAINE, MENTHOLCompass Health Brands Corp.2c25fa5e-9546-ba74-e063-6294a90aadf42025-04-22WarningsExact identifier
application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED BALMLIDOCAINE, MENTHOLCompass Health Brands Corp.2bd8cfb6-ab6c-9e04-e063-6294a90a2d522025-04-22WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINEPharmheal32e57c0f-d138-88dc-e063-6394a90ac0852025-04-16WarningsExact identifier
application number: M017
COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-PatchMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd32b7d73c-a191-7843-e063-6394a90aa6312025-04-14WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEMARCELLA HEALTH32c153c7-de30-504e-e063-6294a90a40202025-04-14WarningsExact identifier
application number: M017
Dollar General Cold-Hot Medicated PatchesMENTHOLDOLGENCORP, LLCe13ab4d3-eb58-4874-925a-6a59df4dd29a2025-04-14WarningsExact identifier
application number: M017
AY BENDITO - PAIN RELIEFCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCb97f6b71-7de7-3217-e053-2a95a90aa4262025-04-14WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCbbf0d85e-269d-0342-e053-2995a90ac63c2025-04-14WarningsExact identifier
application number: M017
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC71a36691-9d9e-479d-bfdc-6f6b192ad2d02025-04-11WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedda3358ae-8679-6045-e053-2a95a90a50e32025-04-10WarningsExact identifier
application number: M017
JointflexJOINTFLEXStrides Consumer LLCb82ec69c-bd00-400b-bd94-ac15fb620f9b2025-04-09WarningsExact identifier
application number: M017
Zepol Topical AnalgesicCAMPHOR, MENTHOLLaboratorios Zepol S.A.ca20ade6-9b35-40bb-b3b2-fc3a0e1eece92025-04-09WarningsExact identifier
application number: M017
JointflexCAMPHORStrides Consumer LLCcb5ca02b-0bc1-4b0b-b4b1-abef3222aa562025-04-09WarningsExact identifier
application number: M017
Foster and Thrive Lidocaine Pain Relief PatchLIDOCAINE 4%Strategic Sourcing Services LLC32456887-aa09-8912-e063-6394a90a4ae72025-04-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2688458camphor 6 % / menthol 1.9 % / methyl salicylate 10 % Topical OintmentPSN31b7f84e-8b66-4d31-8e9c-279d0af2fe6411
2688458camphor 0.06 MG/MG / menthol 0.019 MG/MG / methyl salicylate 0.1 MG/MG Topical OintmentSCD31b7f84e-8b66-4d31-8e9c-279d0af2fe6411
2688458camphor 6 % / menthol 1.9 % / methyl salicylate 10 % Topical OintmentSY31b7f84e-8b66-4d31-8e9c-279d0af2fe6411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48201-004-17482010004171 JAR in 1 BOX (48201-004-17) / 170.1 g in 1 JAR1 jar2015-07-080000-00-00NoNoCurrent