FDA.reportPublic FDA data

Medicated Body

Product NDC
52000-038
11-digit product format
520000038
Labeler code
52000
Product ID
52000-038_6af56e16-5a14-4a8b-9491-6891be500637
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Zinc Oxide
Dosage form
POWDER
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-04
Substance
MENTHOL, UNSPECIFIED FORM; ZINC OXIDE
Active strength
1.5; 10 mg/g; mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Medicated Body
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM1.5 mg/g
ZINC OXIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, SOI2LOH54Z
Rxcui577232

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-038-25Medicated Body283 g in 1 BOTTLEPOWDER2834
52000-038-26Medicated Body226 g in 1 BOTTLEPOWDER2264

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-038MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [UNIVERSAL DISTRIBUTION CENTER LLC]4Current NDC, Legacy NDC, 2 package rows20240627_2a59a847-cc7a-42cf-b49a-92e7254c1629.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577232menthol 0.15 % / zinc oxide 1 % Topical PowderPSN2a59a847-cc7a-42cf-b49a-92e7254c16294
577232menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical PowderSCD2a59a847-cc7a-42cf-b49a-92e7254c16294
577232Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical PowderSY2a59a847-cc7a-42cf-b49a-92e7254c16294
577232menthol 0.15 % / zinc oxide 1 % Topical PowderSY2a59a847-cc7a-42cf-b49a-92e7254c16294

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-038-2552000003825283 g in 1 BOTTLE (52000-038-25) 283 g2017-12-040000-00-00NoNoCurrent
52000-038-2652000003826226 g in 1 BOTTLE (52000-038-26) 226 g2017-12-04NoNoCurrent