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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
630923Internal RxNorm lookup
967558Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f202dd0e-7c61-4ea1-a5f6-e90898366ba3Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Balmex Diaper RashZINC OXIDERandob Labs,Ltd.f202dd0e-7c61-4ea1-a5f6-e90898366ba32018-11-13WarningsExact identifier
ndc (product): 52412-400

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