ASTONEA Cold Ice Analgesic Gel

Product NDC: 77338-402
Requested package NDC: 77338-402-12
11-digit product format: 773380402
Labeler code: 77338
Product ID: 77338-402_ef062334-d7a7-d5de-e053-2995a90aabf5
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: ASTONEA LABS PRIVATE LIMITED
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-04-08
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 5 g/227g
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	77338-402	77338-402-12	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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-402	77338-402-12	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-402	77338-402-12	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-402	77338-402-12	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77338-402-12	2024-06-25	C162847	48780-1	1030e365-2c98-111a-e063-dadaa90a10e2	Astonea Cold Ice Gel
77338-402-12	2024-01-30	C162847	48780-1	1030e365-2c98-111a-e063-dadaa90a10e2	Astonea Cold Ice Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-402-12	ASTONEA Cold Ice Analgesic Gel	227 g in 1 JAR	GEL	227		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-402	ASTONEA COLD ICE ANALGESIC GEL (MENTHOL) GEL [ASTONEA LABS PRIVATE LIMITED]	3	Legacy NDC, 1 package rows	20240627_e5c0c190-042d-616f-e053-2995a90a25d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311502	menthol 2 % Topical Gel	PSN	e5c0c190-042d-616f-e053-2995a90a25d2	3
311502	menthol 0.02 MG/MG Topical Gel	SCD	e5c0c190-042d-616f-e053-2995a90a25d2	3
311502	menthol 2 % Topical Gel	SY	e5c0c190-042d-616f-e053-2995a90a25d2	3
311502	menthol 2 % topical stick	SY	e5c0c190-042d-616f-e053-2995a90a25d2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77338-402-12	77338040212	227 g in 1 JAR (77338-402-12)	227 g	2019-04-08	0000-00-00	No	No	Current