ALORYXA

Product NDC: 87854-001
Requested package NDC: 87854-001-02
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57346a86-ab51-021a-e063-6394a90a1dc2	Available on FDA.report

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 (package): 87854-001-02 ndc (product): 87854-001 ndc11 (package): 87854000102

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
85H0HZU99M	POVIDONE-IODINE	25655-41-8	POVIDONE-IODINE
I8442U2G7J	PORK COLLAGEN		PORK COLLAGEN
BQM438CTEL	EPIGALLOCATECHIN GALLATE	989-51-5	EPIGALLOCATECHIN GALLATE

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