Sani Luxe

Product NDC: 71489-009
Requested package NDC: 71489-009-01
11-digit product format: 714890009
Labeler code: 71489
Product ID: 71489-009_1cc23869-b53e-2a76-e063-6394a90a47cc
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: CLOTH
Route: CUTANEOUS
Labeler: Celeste Industries Corporation
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-02-05
Substance: ALCOHOL
Active strength: .7 mL/mL
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: Sani Luxe
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	.7 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1489307	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ba0f4e72-c50a-41c0-e053-2995a90aeee1	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71489-009-01	2024-01-30	C162847	48780-1	1030e365-13f0-111a-e063-dadaa90a10e2	Sani Luxe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71489-009-01	Sani Luxe	1.75 mL in 1 PACKET	CLOTH	1.75		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71489-009	SANI LUXE (ALCOHOL) CLOTH [CELESTE INDUSTRIES CORPORATION]	4	Current NDC, Legacy NDC, 1 package rows	20240709_ba0f4e72-c50a-41c0-e053-2995a90aeee1.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
Sani Luxe	ALCOHOL	Celeste Industries Corporation	ba0f4e72-c50a-41c0-e053-2995a90aeee1	2024-07-08	Warnings	Exact identifier ndc (package): 71489-009-01 ndc (product): 71489-009 ndc11 (package): 71489000901

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1489307	ethanol 70 % Medicated Pad	PSN	ba0f4e72-c50a-41c0-e053-2995a90aeee1	4
1489307	ethanol 0.7 ML/ML Medicated Pad	SCD	ba0f4e72-c50a-41c0-e053-2995a90aeee1	4
1489307	ethanol 70 % Medicated Pad	SY	ba0f4e72-c50a-41c0-e053-2995a90aeee1	4
1489307	ethanol 70 % Medicated Wipes	SY	ba0f4e72-c50a-41c0-e053-2995a90aeee1	4
1489307	ethyl alcohol 70 % Cloth	SY	ba0f4e72-c50a-41c0-e053-2995a90aeee1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71489-009-01	71489000901	1.75 mL in 1 PACKET (71489-009-01)	1.75 ml	2021-02-05	0000-00-00	No	No	Current