thera plus vitamin a and d cream

Generic: dimethicone, zinc oxide

Labeler: fourstar group usa, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name thera plus vitamin a and d cream
Generic Name dimethicone, zinc oxide
Labeler fourstar group usa, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

dimethicone 10 mg/g, zinc oxide 100 mg/g

Manufacturer
FOURSTAR GROUP USA, INC.

Identifiers & Regulatory

Product NDC 80684-135
Product ID 80684-135_49d87e00-eec1-3209-e063-6294a90afc41
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2025-04-30

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80684135
Hyphenated Format 80684-135

Supplemental Identifiers

RxCUI
686403
UPC
0049696700405
UNII
92RU3N3Y1O SOI2LOH54Z
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name thera plus vitamin a and d cream (source: ndc)
Generic Name dimethicone, zinc oxide (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
  • 100 mg/g
source: ndc
Packaging
  • 42.5 g in 1 TUBE (80684-135-01)
source: ndc

Packages (1)

80684-135-01 42.5 g in 1 TUBE (80684-135-01)

Ingredients (2)

dimethicone (10 mg/g) zinc oxide (100 mg/g)

Linked Drug Pages (1)

Thera Plus Vitamin A and D Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "49d87e00-eec1-3209-e063-6294a90afc41", "openfda": {"nui": ["N0000010282"], "upc": ["0049696700405"], "unii": ["92RU3N3Y1O", "SOI2LOH54Z"], "rxcui": ["686403"], "spl_set_id": ["36f09fa4-a3b8-4104-9745-ee60aa493b06"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["FOURSTAR GROUP USA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "42.5 g in 1 TUBE (80684-135-01)", "package_ndc": "80684-135-01", "marketing_start_date": "20250430"}], "brand_name": "Thera Plus Vitamin A and D Cream", "product_id": "80684-135_49d87e00-eec1-3209-e063-6294a90afc41", "dosage_form": "CREAM", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]", "Skin Barrier Activity [PE]"], "product_ndc": "80684-135", "generic_name": "DIMETHICONE, ZINC OXIDE", "labeler_name": "FOURSTAR GROUP USA, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Thera Plus Vitamin A and D Cream", "active_ingredients": [{"name": "DIMETHICONE", "strength": "10 mg/g"}, {"name": "ZINC OXIDE", "strength": "100 mg/g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250430", "listing_expiration_date": "20271231"}