Home NDC 80684-135-01 Thera Plus Vitamin A and D Cream
Product NDC 80684-135
Requested package NDC 80684-135-01
11-digit product format 806840135
Labeler code 80684
Product ID 80684-135_49d87e00-eec1-3209-e063-6294a90afc41
Type HUMAN OTC DRUG
Nonproprietary name DIMETHICONE, ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler FOURSTAR GROUP USA, INC.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-30
Substance DIMETHICONE; ZINC OXIDE
Active strength 10; 100 mg/g; mg/g
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 Thera Plus Vitamin A and D Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 10 mg/g ZINC OXIDE 100 mg/g
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 686403 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 80684-135-01 Thera Plus Vitamin A and D Cream 42.5 g in 1 TUBE CREAM 42.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80684-135 THERA PLUS VITAMIN A AND D CREAM (DIMETHICONE, ZINC OXIDE) CREAM [FOURSTAR GROUP USA, INC.] 1 Current NDC, 1 package rows 20250430_36f09fa4-a3b8-4104-9745-ee60aa493b06.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 · 1,343 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80684-135-01 80684013501 42.5 g in 1 TUBE (80684-135-01) 42.5 g 2025-04-30 No No Current