FDA.reportPublic FDA data

BALMEX ADULT CARE RASH

Product NDC
52412-500
11-digit product format
524120500
Labeler code
52412
Product ID
52412-500_3b905d74-d3d4-4b83-8c32-3a3ead9d23cc
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 ADULT CARE 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
52412-500-03BALMEX ADULT CARE RASH85 g in 1 TUBECREAM851
52412-500-03BALMEX ADULT CARE RASH1 in 1 CARTONCREAM11
52412-500-12BALMEX ADULT CARE RASH340 g in 1 JARCREAM3401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52412-500-03GM - Gram52412-500c627646f-89a3-4adf-9530-ff403906900812019-08-06
52412-500-12GM - Gram52412-500ada3305f-e82a-4f40-b4c6-cda70bdedc7c12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-500BALMEX ADULT CARE RASH (ZINC OXIDE) CREAM [RANDOB LABS,LTD.]1Current NDC, Legacy NDC, 3 package rows20181114_9443a987-c7b2-4b0d-a9dc-02233135af81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
967558Balmex 11.3 % Topical CreamPSN9443a987-c7b2-4b0d-a9dc-02233135af811
630923zinc oxide 11.3 % Topical CreamPSN9443a987-c7b2-4b0d-a9dc-02233135af811
967558zinc oxide 113 MG/ML Topical Cream [Balmex]SBD9443a987-c7b2-4b0d-a9dc-02233135af811
630923zinc oxide 113 MG/ML Topical CreamSCD9443a987-c7b2-4b0d-a9dc-02233135af811
967558Balmex 11.3 % Topical CreamSY9443a987-c7b2-4b0d-a9dc-02233135af811
967558Balmex 113 MG/ML Topical CreamSY9443a987-c7b2-4b0d-a9dc-02233135af811
967558Balmex Diaper Rash Cream StickSY9443a987-c7b2-4b0d-a9dc-02233135af811
630923zinc oxide 11.3 % Topical CreamSY9443a987-c7b2-4b0d-a9dc-02233135af811
630923ZNO 113 MG/ML Topical CreamSY9443a987-c7b2-4b0d-a9dc-02233135af811
967558ZNO 113 MG/ML Topical Cream [Balmex]SY9443a987-c7b2-4b0d-a9dc-02233135af811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52412-500-03524120500031 TUBE in 1 CARTON (52412-500-03) / 85 g in 1 TUBE1 tube2018-11-010000-00-00NoNoCurrent
52412-500-1252412050012340 g in 1 JAR (52412-500-12) 340 g2018-11-010000-00-00NoNoCurrent