FDA.reportPublic FDA data

Balmex Diaper Rash

Product NDC
52412-400
11-digit product format
524120400
Labeler code
52412
Product ID
52412-400_18af2fdd-d234-4675-afc6-e0bdd19cdbbd
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Randob Labs,Ltd.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-04-27
Substance
ZINC OXIDE
Active strength
.113 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Balmex Diaper Rash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE.113 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui630923, 967558

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-400-02Balmex Diaper Rash1 in 1 CARTONCREAM11
52412-400-02Balmex Diaper Rash56 g in 1 TUBECREAM561
52412-400-04Balmex Diaper Rash113 g in 1 TUBECREAM1131
52412-400-04Balmex Diaper Rash1 in 1 CARTONCREAM11
52412-400-05Balmex Diaper Rash5.1 g in 1 PACKAGECREAM5.11
52412-400-16Balmex Diaper Rash453 g in 1 JARCREAM4531

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52412-400-02GM - Gram52412-40006ff3824-4e22-4167-a4dc-878e0d05d4c212019-08-06
52412-400-04GM - Gram52412-400d8e1c508-907e-4ee1-87bb-6dc564de9fd612019-08-06
52412-400-16GM - Gram52412-4000810bdf1-9738-4b79-acef-f6474874ba5b12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-400BALMEX DIAPER RASH (ZINC OXIDE) CREAM [RANDOB LABS,LTD.]1Current NDC, Legacy NDC, 6 package rows20181114_f202dd0e-7c61-4ea1-a5f6-e90898366ba3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
967558Balmex 11.3 % Topical CreamPSNf202dd0e-7c61-4ea1-a5f6-e90898366ba31
630923zinc oxide 11.3 % Topical CreamPSNf202dd0e-7c61-4ea1-a5f6-e90898366ba31
967558zinc oxide 113 MG/ML Topical Cream [Balmex]SBDf202dd0e-7c61-4ea1-a5f6-e90898366ba31
630923zinc oxide 113 MG/ML Topical CreamSCDf202dd0e-7c61-4ea1-a5f6-e90898366ba31
967558Balmex 11.3 % Topical CreamSYf202dd0e-7c61-4ea1-a5f6-e90898366ba31
967558Balmex 113 MG/ML Topical CreamSYf202dd0e-7c61-4ea1-a5f6-e90898366ba31
967558Balmex Diaper Rash Cream StickSYf202dd0e-7c61-4ea1-a5f6-e90898366ba31
630923zinc oxide 11.3 % Topical CreamSYf202dd0e-7c61-4ea1-a5f6-e90898366ba31
630923ZNO 113 MG/ML Topical CreamSYf202dd0e-7c61-4ea1-a5f6-e90898366ba31
967558ZNO 113 MG/ML Topical Cream [Balmex]SYf202dd0e-7c61-4ea1-a5f6-e90898366ba31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52412-400-02524120400021 TUBE in 1 CARTON (52412-400-02) / 56 g in 1 TUBE1 tube2018-11-010000-00-00NoNoCurrent
52412-400-04524120400041 TUBE in 1 CARTON (52412-400-04) / 113 g in 1 TUBE1 tube2018-11-010000-00-00NoNoCurrent
52412-400-05524120400055.1 g in 1 PACKAGE (52412-400-05) 5.1 g2018-11-010000-00-00NoNoCurrent
52412-400-1652412040016453 g in 1 JAR (52412-400-16) 453 g2018-11-010000-00-00NoNoCurrent