FDA.reportPublic FDA data

Celadrin

Product NDC
54230-356
11-digit product format
542300356
Labeler code
54230
Product ID
54230-356_097fcff2-ea99-0878-e063-6394a90aa0fd
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Factors Group of Nutritional Products
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-01
Substance
MENTHOL
Active strength
12.5 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54230-356-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54230-356-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54230-356-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54230-356-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54230-356-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54230-356-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54230-356-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
Celadrin
Brand name suffix
Joint and Muscle Pain Relieving
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL12.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416982Internal RxNorm lookup
1046429Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6396e4b6-2130-433b-bdb3-97c76dbe685cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54230-356-012023-03-30C16284748780-19d75b9d1-1749-f424-e053-dadaa90a57ceFactors Group (as PLD) - Celadrin Joint and Muscle Pain Relieving Cream (54230-356)
54230-356-012020-01-31C16284748780-19d75b9d1-1749-f424-e053-dadaa90a57ceFactors Group (as PLD) - Celadrin Joint and Muscle Pain Relieving Cream (54230-356)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54230-356-01CeladrinJoint and Muscle Pain Relieving170 g in 1 JARCREAM1703

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3ACELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
MentholACTIVE MOIETYL7T10EIP3ACELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COCELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GCELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1ECELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RCELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHCELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1
WATERINACTIVE INGREDIENT059QF0KO0RCELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54230-356CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]3Current NDC, Legacy NDC, 1 package rows20231107_6396e4b6-2130-433b-bdb3-97c76dbe685c.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 87 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy Hydrocortisone with AloeHYDROCORTISONEAmerisourceBergen0c544792-63d9-400c-9888-207c44fdc75e2025-07-08WarningsExact identifier
application number: M017
Good Neighbor Pharmacy HydrocortisoneHYDROCORTISONEAmerisourceBergen58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf2025-07-08WarningsExact identifier
application number: M017
Publix HydroHYDROCORTISONEPublix Super Markets Inc29296b0f-0eed-4bb9-8727-c25c2bcf9fd62025-07-08WarningsExact identifier
application number: M017
Publix hydro plusHYDROCORTISONEPublix Super Markets Inca00d82c1-6b09-424a-be78-2603eee3fb9d2025-07-08WarningsExact identifier
application number: M017
TattooTATTOO CREAMPerfso (HK) Co., Limited39773cab-12df-4520-e063-6294a90abc5b2025-07-08WarningsExact identifier
application number: M017
Neutrogena Sun Rescue After Sun Medicated ReliefCAMPHOR (SYNTHETIC)Kenvue Brands LLCc95c5b64-b90f-1143-e053-2a95a90aa03c2025-07-07WarningsExact identifier
application number: M017
sunmark HydrocortisoneHYDROCORTISONEStrategic Sourcing Services LLC210079e9-3d2f-4489-b468-b96b145034ed2025-07-07WarningsExact identifier
application number: M017
Relief GelLIDOCAINE HCLGood Clean Love, Inc.e5fa2265-ccb7-750c-e053-2995a90aa51e2025-07-07WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONESun Pharmaceutical Industries, Inc.09ac2749-a60f-4039-8c80-a0d2eaf50c342025-07-07WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESun Pharmaceutical Industries, Inc.2ada9ec2-1c28-4da2-8639-07b3193ffb322025-07-03WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONESun Pharmaceutical Industries, Inc.caa2fd64-e262-4d7c-ad8a-69f506feba8c2025-07-03WarningsExact identifier
application number: M017
Stopain Extra StrengthMENTHOLTroy Manufacturing, Inc.07e9a235-6d10-4407-8729-beaf936e97ad2025-07-03WarningsExact identifier
application number: M017
Blue Ice Topical Analgesic GelICE GELInternational Wholesale397cd306-078d-5b7d-e063-6294a90a8bbc2025-07-03WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINE, MENTHOLVive Health LLC236ccc6d-21b7-6153-e063-6394a90a46342025-07-02WarningsExact identifier
application number: M017
AsperFlex MAXLIDOCAINE 4% WITH MENTHOL 1%Akron Pharma Inc.ccf6172b-350a-4b78-b844-f84bf17c491f2025-07-02WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3766e3a9-94a8-4c3e-e063-6394a90aa24a2025-07-01WarningsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESun Pharmaceutical Industries, Inc.c89e3de8-7d71-485c-8fc5-2832d6024f162025-07-01WarningsExact identifier
application number: M017
Westlake Outdoor Pain and Itch RelievingLIDOCAINE 4% PAIN AND ITCH RELIEVINGWESTLAKE HB PHARMA3c563b28-4f4f-9d0c-e063-6294a90adf732025-07-01WarningsExact identifier
application number: M017
Cortizone 10 Water ResistantHYDROCORTISONEChattem, Inc.118e55e7-241f-44c4-959e-09bf6221bd772025-07-01WarningsExact identifier
application number: M017
Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.38c1616e-3b09-0669-e063-6294a90a2c862025-06-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046429Celadrin 1.25 % Topical CreamPSN6396e4b6-2130-433b-bdb3-97c76dbe685c3
416982menthol 1.25 % Topical CreamPSN6396e4b6-2130-433b-bdb3-97c76dbe685c3
1046429menthol 12.5 MG/ML Topical Cream [Celadrin]SBD6396e4b6-2130-433b-bdb3-97c76dbe685c3
416982menthol 12.5 MG/ML Topical CreamSCD6396e4b6-2130-433b-bdb3-97c76dbe685c3
1046429Celadrin 1.25 % Topical CreamSY6396e4b6-2130-433b-bdb3-97c76dbe685c3
1046429Celadrin 12.5 MG/ML Topical CreamSY6396e4b6-2130-433b-bdb3-97c76dbe685c3
1046429Celadrin Cream 12.5 MG/ML Topical CreamSY6396e4b6-2130-433b-bdb3-97c76dbe685c3
416982menthol 1.25 % Topical CreamSY6396e4b6-2130-433b-bdb3-97c76dbe685c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54230-356-0154230035601170 g in 1 JAR (54230-356-01) 170 g2012-10-01NoNoCurrent