Home NDC 68828-700 Tender Moments Delicate Baby Diaper Rash Balm
Product NDC 68828-700
11-digit product format 688280700
Labeler code 68828
Product ID 68828-700_4ced5cfb-b40e-968f-e063-6394a90a80f5
Type HUMAN OTC DRUG
Nonproprietary name DIMETHICONE,ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Distribuidora Comercial Jafra, S.A. de C.V.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-29
Substance DIMETHICONE; ZINC OXIDE
Active strength 2; 10 g/100mL; g/100mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tender Moments Delicate Baby Diaper Rash Balm
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 2 g/100mL ZINC OXIDE 10 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2562886 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68828-700-01 Tender Moments Delicate Baby Diaper Rash Balm 50 mL in 1 TUBE CREAM 50 7 68828-700-01 Tender Moments Delicate Baby Diaper Rash Balm 1 in 1 CARTON CREAM 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68828-700 TENDER MOMENTS DELICATE BABY DIAPER RASH BALM (DIMETHICONE,ZINC OXIDE) CREAM [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.] 5 Current NDC, Legacy NDC, 2 package rows 20250104_f09ba452-e1a6-4f45-901f-bb63d4f8e884.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 38 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68828-700-01 68828070001 1 TUBE in 1 CARTON (68828-700-01) / 50 mL in 1 TUBE 1 tube 2021-12-29 0000-00-00 No No Current