Home NDC 55528-400 Alpha-H Total Eclipse
Product NDC 55528-400
11-digit product format 555280400
Labeler code 55528
Product ID 55528-400_43908af3-3a7d-4e13-e063-6394a90a47c2
Type HUMAN OTC DRUG
Nonproprietary name Titanium dioxide, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Alpha-H
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-05
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 9.7; 19.4 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Alpha-H Total Eclipse
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 9.7 mg/mL TITANIUM DIOXIDE 19.4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55528-400-01 Alpha-H Total Eclipse 40 mL in 1 TUBE LOTION 40 4 55528-400-02 Alpha-H Total Eclipse 1 in 1 CARTON LOTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55528-400 ALPHA-H TOTAL ECLIPSE (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ALPHA-H] 2 Current NDC, 2 package rows 20241009_fc8a4efe-7d5e-5f44-e053-6394a90a80aa.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55528-400-01 55528040001 40 mL in 1 TUBE 40 ml Historical 55528-400-02 55528040002 1 TUBE in 1 CARTON (55528-400-02) / 40 mL in 1 TUBE (55528-400-01) 1 tube 2023-05-05 No No Current