FDA.reportPublic FDA data

MAG 5 PT WARMING FORMULA

Product NDC
76348-511
11-digit product format
763480511
Labeler code
76348
Product ID
76348-511_574988ea-50c0-bcb0-e063-6294a90ad749
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
RENU LABORATORIES, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-19
Substance
MENTHOL
Active strength
5.6 g/112g
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
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76348-511-05IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76348-511-05IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76348-511-05IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76348-511-05IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76348-511-05UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76348-511-05UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76348-511-05UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
MAG 5 PT WARMING FORMULA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.6 g/112g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
a499ac9b-0e8e-e23f-e053-2a95a90abe9aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-03-27MAG 5 PT WARMING FORMULA RECOVERY CREAM
2025-03-27MAG 5 PT WARMING FORMULA RECOVERY CREAM
2025-01-30MAG 5 PT WARMING FORMULA RECOVERY CREAM
2025-01-30MAG 5 PT WARMING FORMULA RECOVERY CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-511-04MAG 5 PT WARMING FORMULA112 g in 1 JARCREAM11210
76348-511-05MAG 5 PT WARMING FORMULA1 in 1 BOXCREAM110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-511MAG 5 PT WARMING FORMULA (MENTHOL) CREAM [RENU LABORATORIES, LLC]9Current NDC, 2 package rows20250330_a499ac9b-0e8e-e23f-e053-2a95a90abe9a.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 125 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Bruise and Pain Relief Maximum StrengthCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions240b231d-a8b2-c64c-e063-6394a90a74402024-10-09WarningsExact identifier
application number: M017
Muscle Freeze ReliefMENTHOLNATURAL ESSENTIALS, INC.815c534b-096d-49f2-b5f2-8c885d45a5e62024-10-09WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC2410dc2f-9332-19fa-e063-6394a90a28352024-10-09WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain-RelievingLIDOCAINENatural Essentials, Inc.fc23b2e2-4abc-4119-b8bd-305b4327f1dd2024-10-09WarningsExact identifier
application number: M017
KERACAREMENTHOL 1%Avlon Industries, Inc.f72eec6d-1204-4e03-8aed-d5bcf8d3bbce2024-10-09WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharma, PTda338796-de9c-be51-e053-2a95a90a25092024-10-07WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharmae2c5f821-cdd5-190d-e053-2a95a90a91592024-10-07WarningsExact identifier
application number: M017
NanoXtreme Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLCc1490c30-a9db-4120-adaf-9e8000169e462024-10-07WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incea656cf8-cad5-4fa5-82e7-daec77a0bb042024-10-07WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEEagle Indo Pharma, PTe2729023-d689-7ae2-e053-2a95a90a78dc2024-10-06WarningsExact identifier
application number: M017
Flanax Back Pain ReliefLIDOCAINEBelmora LLC46d33346-e582-4af1-b81a-feca7033dceb2024-10-04WarningsExact identifier
application number: M017
Muscle BalmMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)Natural Essentials, Inc.16918ba3-2e07-4232-9ed3-4c7751796cd22024-10-04WarningsExact identifier
application number: M017
Fast Freeze Pain Relieving ContinuousMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.998a4824-9ed9-4fe0-b45b-72e52861fcd32024-10-04WarningsExact identifier
application number: M017
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
application number: M017
Fast Freeze LidocaineLIDOCAINENatural Essentials, Inc.029bd3fb-1b5b-48e0-b9af-d91d548b5b0f2024-10-04WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.a96e3e41-871c-4cf3-93b6-af2a6246ded82024-10-04WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOL 4%CVS20234356-5e80-b79e-e063-6294a90a2ee32024-10-04WarningsExact identifier
application number: M017
FLANAX BACK PAIN RELIEFLIDOCAINEBelmora Llcaf4bf57c-f250-4506-83eb-e0f253e960622024-10-04WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC11a30ec9-ebc2-4a00-8a8d-431d0d973b372024-10-03WarningsExact identifier
application number: M017
pain relief patchLIDOCAINE 4%Bionpharma Inc.19c69983-4e78-8ec5-e063-6394a90a84be2024-10-03WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76348-511-0476348051104112 g in 1 JAR112 gHistorical
76348-511-05763480511051 JAR in 1 BOX (76348-511-05) / 112 g in 1 JAR (76348-511-04) 1 jar2019-03-19NoNoCurrent