Home NDC 80684-135 Thera Plus Vitamin A and D Cream
Product NDC 80684-135
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 14 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic Spearmint SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4523af69-1a0d-6d18-e063-6394a90ad9d1 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me Cherry LIP BALM SKIN PROTECTANT Suave Brands Company 47a2487d-b2e5-7195-e063-6394a90ae481 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Cherry SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4512b5a0-ce1f-c53e-e063-6294a90a56b6 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Strawberry SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 42770fff-d70a-d9d1-e063-6294a90aa98d 2026-03-30 Warnings Exact identifier application number: M016 Aveeno Skin Relief Healing GLYCERIN Kenvue Brands LLC 345fdde5-700b-7103-e063-6394a90a0e3e 2026-03-27 Warnings Exact identifier application number: M016 Critic Aid Clear PETROLATUM Coloplast Corp 0b6da97e-519b-4579-9895-f4ede5c48b47 2026-03-27 Warnings Exact identifier application number: M016 Baza Protect ZINC OXIDE AND DIMETHICONE Coloplast Corp 256dfcfc-a91c-49b0-9439-452586a0880e 2026-03-27 Warnings Exact identifier application number: M016 Sween 24 DIMETHICONE Coloplast Corp a623c8d7-8db0-410a-9980-02ac02f7b6ea 2026-03-27 Warnings Exact identifier application number: M016 Baza Cleanse and Protect Odor Control DIMETHICONE Coloplast Corp ca5fa4ae-c18d-4457-b520-4a9318ea821f 2026-03-27 Warnings Exact identifier application number: M016 Baza Cleanse and Protect DIMETHICONE Coloplast Corp 82eff041-0c9d-4261-a6b6-5a041a660074 2026-03-27 Warnings Exact identifier application number: M016 Baza Clear PETROLATUM Coloplast Corp 69d9f456-1a35-4146-8366-c0285648a172 2026-03-27 Warnings Exact identifier application number: M016 Vitamin A D LANOLIN, PETROLATUM Topco Associates LLC 5126fdf6-5df5-474b-bc0d-3a82dea61abb 2026-03-26 Warnings, Adverse reactions Exact identifier application number: M016 Advanced Healing PETROLATUM Amazon.com Services LLC cdf1bd12-ac59-4f06-be0f-ef6eb3caeeff 2026-03-26 Warnings, Adverse reactions Exact identifier application number: M016 Dynashield with Dimethicone ZINC OXIDE Dynarex Corporation b5dcf9e8-4689-4a08-ae73-3a859b4cbffe 2026-03-26 Warnings Exact identifier application number: M016 Eczema Relief Cream COLLOIDAL OATMEAL Lavior Pharma Inc bdd2fc9f-2718-1d88-e053-2995a90a8682 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f2dec8-7ffc-fc3e-e063-6294a90a76ff 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f33001-7fec-682e-e063-6394a90a9428 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f3b300-f32f-8881-e063-6394a90a1a2a 2026-03-26 Warnings Exact identifier application number: M016 White Petrolatum PETROLATUM Dynarex Corporation 81f5092d-0632-bf47-e053-2991aa0ac563 2026-03-25 Warnings Exact identifier application number: M016 MYEVER ESTRIOL CREAM Hubei Redrui Building Materials Co., Ltd. 3ed85485-a441-4c05-e063-6394a90afef5 2026-03-25 Warnings Exact identifier application number: M016
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