FDA.reportPublic FDA data

Medicated Body

Product NDC
30400-506
11-digit product format
304000506
Labeler code
30400
Product ID
30400-506_5db8c734-fcb3-4378-e063-6394a90afb18
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
POWDER
Route
TOPICAL
Labeler
Jell Pharmaceuticals Pvt Ltd
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-01
Substance
MENTHOL
Active strength
.42 g/283g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Medicated Body
Brand name suffix
Powder
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.42 g/283g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30400-506-01Medicated BodyPowder283 g in 1 BOTTLEPOWDER2832

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30400-506MEDICATED BODY POWDER (MENTHOL) POWDER [JELL PHARMACEUTICALS PVT LTD]2Current NDC, Legacy NDC, 1 package rows20241220_cdaaf8cd-1bcc-bf8c-e053-2a95a90af887.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 57 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Up and Up Daily MoisturizingDIMETHICONETARGET CORPORATIONf118e0eb-1e66-50ab-e053-2995a90a2cb92024-10-14WarningsExact identifier
application number: M016
Target Up and Up Petroleum JellyWHITE PETROLATUMTARGET CORPORATIONbaeaf660-ac4f-1ebc-e053-2995a90ac0c12024-10-14WarningsExact identifier
application number: M016
Target Up and Up Healing Petrolatum Skin ProtectantPETROLATUMTARGET CORPORATIONf9b62cd9-94ec-26b4-e053-6394a90a82672024-10-14WarningsExact identifier
application number: M016
COCOA BUTTER PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCc1b10d34-2905-4ad6-8f90-7f9800de2b462024-10-14WarningsExact identifier
application number: M016
Gentle STEPS vitamins A and D Diaper Rash and Skin ProtectantLANOLIN, PETROLATUMOld East Main CO.1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d2024-10-11WarningsExact identifier
application number: M016
McKesson Skin ProtectantZINC OXIDEMcKesson Medical-Surgical Inc.50b2709d-aab1-42d8-8ebd-bfd2e1ac6a7b2024-10-11WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LPe1089e9a-ecaa-5c65-e053-2995a90a86992024-10-10WarningsExact identifier
application number: M016
Attitude Diaper Cream Zinc UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)00283894-ddc6-0faa-e063-6394a90ae47c2024-10-02WarningsExact identifier
application number: M016
DermacinRx Zinc Oxide Skin HealingZINC OXIDEPureTek Corporation541b8da8-f0c1-4f57-94a7-193084d9a6112024-10-02WarningsExact identifier
application number: M016
DimopairDIMETHICONEPureTek Corporationdc16af56-b97d-c17f-e053-2995a90a55a02024-10-01WarningsExact identifier
application number: M016
Skin Repair ComplexDIMETHICONEPureTek Corporation1c3059c5-5f7e-264e-e054-00144ff8d46c2024-10-01WarningsExact identifier
application number: M016
Barrier Build Skin Protectant CreamCOLLOIDAL OATMEALILIA, Inc.231d41b8-2a56-6eb8-e063-6394a90ac64f2024-09-27WarningsExact identifier
application number: M016
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.229ee3a7-4129-7b59-e063-6394a90a6f402024-09-23WarningsExact identifier
application number: M016
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.006e457d-bfcd-791a-e063-6294a90a8d662024-09-23WarningsExact identifier
application number: M016
daburZINC OXIDEDabur India Limited22cd1e7a-5448-b3f6-e063-6394a90a880d2024-09-23WarningsExact identifier
application number: M016
DABUR Vitamin A and DWHITE PETROLATUMDabur India Limited22cd44ef-4b02-604d-e063-6394a90a7a0a2024-09-23WarningsExact identifier
application number: M016
DABUR ZINC OXIDE 3.8%ZINC OXIDEDabur India Limited2290bbe2-8a88-b94e-e063-6294a90a7e382024-09-20WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLCb34c8e71-7fad-484c-b387-3c424f50b7432024-09-19WarningsExact identifier
application number: M016
Evereden Intensive Eczema BalmCOLLOIDAL OATMEALEden Brands Inc.2243d4ca-5ca4-54d0-e063-6394a90a39402024-09-16WarningsExact identifier
application number: M016
Whipped GelCOLLOIDAL OATMEALOCEAN OLIVE LLC222b381c-665e-177d-e063-6394a90a33062024-09-15WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1431703menthol 0.15 % Topical PowderPSNcdaaf8cd-1bcc-bf8c-e053-2a95a90af8872
1431703menthol 0.0015 MG/MG Topical PowderSCDcdaaf8cd-1bcc-bf8c-e053-2a95a90af8872
1431703menthol 0.15 % Topical PowderSYcdaaf8cd-1bcc-bf8c-e053-2a95a90af8872
1431703menthol 1.5 MG per GM Topical PowderSYcdaaf8cd-1bcc-bf8c-e053-2a95a90af8872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30400-506-0130400050601283 g in 1 BOTTLE (30400-506-01) 283 g2020-09-010000-00-00NoNoCurrent
30400-506-0330400050603396 g in 1 BOTTLE (30400-506-03) 396 g2020-09-01NoNoCurrent
30400-506-0430400050604113 g in 1 BOTTLE (30400-506-04) 113 g2020-09-01NoNoCurrent