Home NDC 52389-173 Prosacea
Product NDC 52389-173
11-digit product format 523890173
Labeler code 52389
Product ID 52389-173_41afadd5-cb8a-259f-e063-6394a90ab108
Type HUMAN OTC DRUG
Nonproprietary name Sulphur
Dosage form GEL
Route TOPICAL
Labeler Kobayashi Healthcare International, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2006-02-06
Substance SULFUR
Active strength 1 [hp_X]/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Prosacea
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFUR 1 [hp_X]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 70FD1KFU70 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 52389-173-01 Prosacea 21 g in 1 TUBE GEL 21 11 52389-173-21 Prosacea 1 in 1 CARTON GEL 1 11 52389-173-42 Prosacea 2 in 1 CARTON GEL 2 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Sulfur ACTIVE INGREDIENT 70FD1KFU70 PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Sulfur ACTIVE MOIETY 70FD1KFU70 PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 CARBOMER 934 INACTIVE INGREDIENT Z135WT9208 PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Lactose INACTIVE INGREDIENT J2B2A4N98G PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52389-173 PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] 10 Current NDC, Legacy NDC, 3 package rows 20240509_e5907672-3ee1-44d3-9c92-6345ad3f4238.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52389-173-01 52389017301 21 g in 1 TUBE 21 g Historical 52389-173-21 52389017321 1 TUBE in 1 CARTON (52389-173-21) / 21 g in 1 TUBE (52389-173-01) 1 tube 2006-02-06 0000-00-00 No No Current 52389-173-42 52389017342 2 TUBE in 1 CARTON (52389-173-42) / 21 g in 1 TUBE (52389-173-01) 2 tube 2020-02-03 0000-00-00 No No Current