Nite

Product NDC: 85094-708
Requested package NDC: 85094-708-01
11-digit product format: 850940708
Labeler code: 85094
Product ID: 85094-708_2aa6ed27-6b91-92c2-e063-6394a90a2a12
Type: HUMAN OTC DRUG
Nonproprietary name: Personal Lubricant Lotion
Dosage form: OIL
Route: RECTAL; VAGINAL
Labeler: Nite Storm LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2025-01-01
Substance: HYDROXYETHYL CELLULOSE (140 CPS AT 5%)
Active strength: .38 g/75mL
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: Nite
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	.38 g/75mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8136Y38GY5	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
2aa6ed27-6b90-92c2-e063-6394a90a2a12	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85094-708-01	Nite	75 mL in 1 TUBE	OIL	75		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85094-708	NITE (PERSONAL LUBRICANT LOTION) OIL [NITE STORM LLC]	1	Current NDC, 1 package rows	20250104_2aa6ed27-6b90-92c2-e063-6394a90a2a12.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nite	PERSONAL LUBRICANT LOTION	Nite Storm LLC	2aa6ed27-6b90-92c2-e063-6394a90a2a12	2025-01-01	Warnings	Exact identifier ndc (package): 85094-708-01 ndc (product): 85094-708 ndc11 (package): 85094070801

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85094-708-01	85094070801	75 mL in 1 TUBE (85094-708-01)	75 ml	2025-01-01	Yes	No	Current