SANO TI AMO RELIEF AND REPAIR PAIN RELIEF

Product NDC: 80216-111
Requested package NDC: 80216-111-02
11-digit product format: 802160111
Labeler code: 80216
Product ID: 80216-111_052ea67f-e484-4ac7-91d9-a474b49bc554
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)
Dosage form: CREAM
Route: TOPICAL
Labeler: Sano Ti Amo, LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2019-10-08
Marketing end: 0000-00-00
Substance: CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM
Active strength: 3 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	80216-111	80216-111-02	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-03-21	DRUG FACTS
2025-01-30	DRUG FACTS
2022-02-16	DRUG FACTS
2022-01-28	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80216-111-02	SANO TI AMO RELIEF AND REPAIR PAIN RELIEF	60 mL in 1 CONTAINER	CREAM	60		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80216-111	SANO TI AMO RELIEF AND REPAIR PAIN RELIEF (MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)) CREAM [SANO TI AMO, LLC]	4	Legacy NDC, 1 package rows	20250323_205a89c4-2ae4-4072-af5c-a9ce6154a3f9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80216-111-02	80216011102	60 mL in 1 CONTAINER (80216-111-02)	60 ml	2019-10-08	0000-00-00	No	No	Current