Home NDC 69435-1501 Botao Baby Diaper Rash Cream
Product NDC 69435-1501
11-digit product format 694351501
Labeler code 69435
Product ID 69435-1501_48300ffa-cb19-1829-e063-6294a90a3054
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Peer Pharm Ltd.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-19
Substance ZINC OXIDE
Active strength 9 g/71g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [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 Botao Baby Diaper Rash Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 9 g/71g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69435-1501-1 Botao Baby Diaper Rash Cream 70.8 g in 1 TUBE, WITH APPLICATOR CREAM 70.8 3 69435-1501-2 Botao Baby Diaper Rash Cream 1 in 1 BOX CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69435-1501 BOTAO BABY DIAPER RASH CREAM (ZINC OXIDE) CREAM [PEER PHARM LTD.] 2 Current NDC, Legacy NDC, 2 package rows 20240201_df60a70e-e6c0-41b3-e053-2995a90af176.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 39 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69435-1501-1 69435150101 70.8 g in 1 TUBE, WITH APPLICATOR 70.8 g Historical 69435-1501-2 69435150102 1 TUBE, WITH APPLICATOR in 1 BOX (69435-1501-2) / 70.8 g in 1 TUBE, WITH APPLICATOR (69435-1501-1) 2022-05-19 0000-00-00 No No Current