Diaper Rash Cream 40% ZINC

Product NDC
77338-164
11-digit product format
773380164
Labeler code
77338
Product ID
77338-164_16da8bcf-3e86-f435-e063-6294a90a7c8c
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-06
Substance
ZINC OXIDE
Active strength
40 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diaper Rash Cream 40% ZINC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE40 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui1305337

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-164-01Diaper Rash Cream 40% ZINC57 g in 1 TUBECREAM571
77338-164-01Diaper Rash Cream 40% ZINC1 in 1 BOXCREAM11
77338-164-02Diaper Rash Cream 40% ZINC71 g in 1 TUBECREAM711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-164DIAPER RASH CREAM 40% ZINC (ZINC OXIDE) CREAM [ASTONEA LABS PRIVATE LIMITED]1Current NDC, 3 package rows20240426_16da985a-6210-ec82-e063-6294a90a132d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305337zinc oxide 40 % Topical CreamPSN16da985a-6210-ec82-e063-6294a90a132d1
1305337zinc oxide 400 MG/ML Topical CreamSCD16da985a-6210-ec82-e063-6294a90a132d1
1305337zinc oxide 40 % Topical CreamSY16da985a-6210-ec82-e063-6294a90a132d1
1305337ZNO 400 MG/ML Topical CreamSY16da985a-6210-ec82-e063-6294a90a132d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
77338-164-01773380164011 TUBE in 1 BOX (77338-164-01) / 57 g in 1 TUBE1 tube2024-03-06NoNoCurrent
77338-164-027733801640271 g in 1 TUBE (77338-164-02) 71 g2024-03-06NoNoCurrent