ASTONEA

Product NDC: 77338-304
11-digit product format: 773380304
Labeler code: 77338
Product ID: 77338-304_e68b3524-ed6f-55ec-e053-2995a90ab29c
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: OINTMENT
Route: TOPICAL
Labeler: ASTONEA LABS PRIVATE LIMITED
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-05-23
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 20 g/100g
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	77338-304		I	Inactivated by FDA	2026-10-05
excluded package	package	77338-304	77338-304-03	I	Inactivated by FDA	2026-10-05
excluded package	package	77338-304	77338-304-04	I	Inactivated by FDA	2026-10-05
excluded package	package	77338-304	77338-304-05	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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-304-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-304-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-304-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-304-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-304-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-304-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-304-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-304-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-304-04	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
77338-304-03	2026-01-29	ASTONEA Zinc oxide 20%
77338-304-04	2026-01-29	ASTONEA Zinc oxide 20%
77338-304-05	2026-01-29	ASTONEA Zinc oxide 20%
77338-304-03	2024-06-25	ASTONEA Zinc oxide 20%
77338-304-04	2024-06-25	ASTONEA Zinc oxide 20%
77338-304-05	2024-06-25	ASTONEA Zinc oxide 20%
77338-304-03	2024-01-30	ASTONEA Zinc oxide 20%
77338-304-04	2024-01-30	ASTONEA Zinc oxide 20%
77338-304-05	2024-01-30	ASTONEA Zinc oxide 20%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77338-304-03	ASTONEA	28.3 g in 1 TUBE	OINTMENT	28.3	2
77338-304-04	ASTONEA	56.6 g in 1 TUBE	OINTMENT	56.6	2
77338-304-05	ASTONEA	425 g in 1 JAR	OINTMENT	425	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-304	ASTONEA (ZINC OXIDE) OINTMENT [ASTONEA LABS PRIVATE LIMITED]	2	Legacy NDC, 3 package rows	20240627_e68b34ea-0cb3-574f-e053-2995a90ad828.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198911	zinc oxide 20 % Topical Ointment	PSN	e68b34ea-0cb3-574f-e053-2995a90ad828	2
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	e68b34ea-0cb3-574f-e053-2995a90ad828	2
198911	zinc oxide 20 % Topical Ointment	SY	e68b34ea-0cb3-574f-e053-2995a90ad828	2
198911	zinc oxide 200 MG per GM Topical Ointment	SY	e68b34ea-0cb3-574f-e053-2995a90ad828	2
198911	ZNO 0.2 MG/MG Topical Ointment	SY	e68b34ea-0cb3-574f-e053-2995a90ad828	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77338-304-03	77338030403	28.3 g in 1 TUBE (77338-304-03)	28.3 g	2013-05-23	0000-00-00	No	No	Current
77338-304-04	77338030404	56.6 g in 1 TUBE (77338-304-04)	56.6 g	2013-05-23	0000-00-00	No	No	Current
77338-304-05	77338030405	425 g in 1 JAR (77338-304-05)	425 g	2013-05-23	0000-00-00	No	No	Current