Home NDC 87854-001 ALORYXA
Product NDC 87854-001
11-digit product format 878540001
Labeler code 87854
Product ID 87854-001_57346a86-ab52-021a-e063-6394a90a1dc2
Type HUMAN OTC DRUG
Nonproprietary name GYNECOLOGICAL INTIMATE CARE Gel
Dosage form GEL
Route TOPICAL
Labeler Tupelo Brittany LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-07-22
Substance POVIDONE-IODINE; PORK COLLAGEN; EPIGALLOCATECHIN GALLATE
Active strength .1; .02; .01 g/100g; g/100g; g/100g
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 ALORYXA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE-IODINE .1 g/100g PORK COLLAGEN .02 g/100g EPIGALLOCATECHIN GALLATE .01 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 85H0HZU99M Internal UNII lookup I8442U2G7J Internal UNII lookup BQM438CTEL Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ALORYXA GYNECOLOGICAL INTIMATE CARE GEL Tupelo Brittany LLC 57346a86-ab51-021a-e063-6394a90a1dc2 2026-07-22 Warnings Exact identifier ndc (product): 87854-001
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87854-001-02 87854000102 7 VIAL in 1 BOX (87854-001-02) / 3 g in 1 VIAL (87854-001-01) 7 vial 2026-07-22 No No Current