Home NDC 10056-025 g and h Protect Body
Product NDC 10056-025
11-digit product format 100560025
Labeler code 10056
Product ID 10056-025_085bcc1d-8ef6-1348-e063-6394a90af6cf
Type HUMAN OTC DRUG
Nonproprietary name ENSULIZOLE, OCTISALATE, ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler Access Business Group LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-10
Substance ENSULIZOLE; OCTISALATE; ZINC OXIDE
Active strength 17; 50; 165.55 mg/mL; mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 g and h Protect Body
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENSULIZOLE 17 mg/mL OCTISALATE 50 mg/mL ZINC OXIDE 165.55 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9YQ9DI1W42 Internal UNII lookup 4X49Y0596W Internal UNII lookup SOI2LOH54Z Internal UNII 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 10056-025-00 g and h Protect Body 100 mL in 1 TUBE LOTION 100 4 10056-025-00 g and h Protect Body 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 10056-025 G AND H PROTECT BODY (ENSULIZOLE, OCTISALATE, ZINC OXIDE) LOTION [ACCESS BUSINESS GROUP LLC] 4 Current NDC, 2 package rows 20231023_03768ff4-0c67-48b3-a2f3-321d0a6790e8.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 10056-025-00 10056002500 1 TUBE in 1 CARTON (10056-025-00) / 100 mL in 1 TUBE 1 tube 2023-07-10 No No Current