FDA.reportPublic FDA data

Studio 35 External Analgesic Medicated Body

Product NDC
0363-0552
11-digit product format
003630552
Labeler code
0363
Product ID
0363-0552_4807fb60-8d08-6e61-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Zinc Oxide
Dosage form
POWDER
Route
TOPICAL
Labeler
Walgreen Co
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-02-07
Substance
MENTHOL; 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
Studio 35 External Analgesic Medicated Body
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1.5 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
0363-0552-38Studio 35 External Analgesic Medicated Body283 g in 1 BOTTLEPOWDER2831

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0552STUDIO 35 EXTERNAL ANALGESIC MEDICATED BODY (MENTHOL AND ZINC OXIDE) POWDER [WALGREEN CO]1Current NDC, Legacy NDC, 1 package rows20170208_2dd63063-45c1-4029-99ac-0962a27a5ddc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577232menthol 0.15 % / zinc oxide 1 % Topical PowderPSN2dd63063-45c1-4029-99ac-0962a27a5ddc1
577232menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical PowderSCD2dd63063-45c1-4029-99ac-0962a27a5ddc1
577232Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical PowderSY2dd63063-45c1-4029-99ac-0962a27a5ddc1
577232menthol 0.15 % / zinc oxide 1 % Topical PowderSY2dd63063-45c1-4029-99ac-0962a27a5ddc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0552-3800363055238283 g in 1 BOTTLE (0363-0552-38) 283 g2017-02-070000-00-00NoNoCurrent