Astonea

Product NDC: 77338-307
11-digit product format: 773380307
Labeler code: 77338
Product ID: 77338-307_1bbb6d64-77d3-86e2-e063-6294a90abdc4
Type: HUMAN OTC DRUG
Nonproprietary name: White Petrolatum
Dosage form: OINTMENT
Route: TOPICAL
Labeler: ASTONEA LABS PRIVATE LIMITED
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-05-23
Substance: PETROLATUM
Active strength: 76 g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 15 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	77338-307-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-307-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-307-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-307-04	`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	77338-307-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-307-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-307-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-307-04	`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	77338-307-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-307-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-307-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-307-04	`1332a3947898…`	`d4bfe170f9cd…`

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: Astonea
Brand name suffix: Vitamin A and D
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PETROLATUM	76 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049072	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
ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
77338-307-02	2024-06-25	VITAMIN A&D
77338-307-03	2024-06-25	VITAMIN A&D
77338-307-04	2024-06-25	VITAMIN A&D
77338-307-05	2024-06-25	VITAMIN A&D
77338-307-02	2024-01-30	VITAMIN A&D
77338-307-03	2024-01-30	VITAMIN A&D
77338-307-04	2024-01-30	VITAMIN A&D
77338-307-05	2024-01-30	VITAMIN A&D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77338-307-02	AstoneaVitamin A and D	5 g in 1 PACKET	OINTMENT	5	2
77338-307-03	AstoneaVitamin A and D	28.3 g in 1 TUBE	OINTMENT	28.3	2
77338-307-04	AstoneaVitamin A and D	113 g in 1 TUBE	OINTMENT	113	2
77338-307-05	AstoneaVitamin A and D	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
77338-307	ASTONEA VITAMIN A AND D (WHITE PETROLATUM) OINTMENT [ASTONEA LABS PRIVATE LIMITED]	2	Current NDC, Legacy NDC, 4 package rows	20240627_ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf.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 22 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petroleum	WHITE PETROLATUM	Harris Teeter	de380df6-cc6e-4b2a-98de-fc08eeb6e8ea	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Hy-Vee, Inc.	45867f42-9562-c111-e063-6394a90adb70	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Lidl US, LLC	c82f236d-c27f-458c-bcd8-19877d09e9a3	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Lidl US, LLC	5e83811f-773f-43e7-bab8-f9e558fb0e00	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Major Pharmaceuticals	c25be68d-834a-4959-8d47-01ec789406ba	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Major Pharmaceuticals	0e7e11c5-a1f8-43c4-b8a6-211491052404	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	d76e116f-4b22-4633-8487-17ad3b5778c7	2026-02-04	Warnings	Exact identifier application number: M016
Comforts Petroleum Jelly	WHITE PETROLATUM	KROGER	3feb3638-1cdc-62d4-e063-6294a90a1d89	2026-02-03	Warnings	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	CVS Pharmacy, Inc.	edc20df4-561e-486f-b9f1-900672a0f2a4	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	CVS Pharmacy, Inc.	a153842c-d9ce-4658-912b-362a6f20b0aa	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Demoulas Super Markets, Inc	702215f0-4cfd-4a23-b47a-da691c136634	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M016
Neurexa	COLLOIDAL OATMEAL	METHODIQ INC.	494d7915-acad-260e-e063-6394a90a182c	2026-02-03	Warnings	Exact identifier application number: M016
Thera Plus Vitamin A and D Cream	DIMETHICONE, ZINC OXIDE	FOURSTAR GROUP USA, INC.	36f09fa4-a3b8-4104-9745-ee60aa493b06	2026-02-02	Warnings	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Kroger Co.	b4aa9b58-d95e-4dac-9a34-213482e8ca34	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M016
Nail Nourishing Pen	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	49e45462-a05f-d370-e063-6394a90a1e0f	2026-02-02	Warnings	Exact identifier application number: M016
Barrier Repair Cream	CREAM	Steel City Health Private Limited	4842f653-7137-eca4-e063-6394a90a8c55	2026-01-31	Warnings	Exact identifier application number: M016
Cracked Heel Repair Balm	DIMETHICONE	Delta Brands Inc.	42b7c9f8-0557-8e33-e063-6394a90a5919	2026-01-30	Warnings	Exact identifier application number: M016
Readybath TPC Total Perineal Care	DIMETHICONE	Medline Industries, Inc.	43a3f0f7-f76f-434d-a21f-7eaa3638913d	2026-01-30	Warnings	Exact identifier application number: M016
Lanolin, Petrolatum	LANOLIN, PETROLATUM	Rite Aid Corporation	1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Rite Aid Corporation	3af9f0e5-0d79-4178-b29e-3b60735bf4ce	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049072	petrolatum 76 % Topical Ointment	PSN	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2
1049072	petrolatum 0.76 MG/MG Topical Ointment	SCD	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2
1049072	petrolatum 76 % Topical Ointment	SY	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77338-307-02	77338030702	5 g in 1 PACKET (77338-307-02)	5 g	2013-05-23	0000-00-00	No	No	Current
77338-307-03	77338030703	28.3 g in 1 TUBE (77338-307-03)	28.3 g	2013-05-23	0000-00-00	No	No	Current
77338-307-04	77338030704	113 g in 1 TUBE (77338-307-04)	113 g	2013-05-23	0000-00-00	No	No	Current
77338-307-05	77338030705	425 g in 1 JAR (77338-307-05)	425 g	2013-05-23	0000-00-00	No	No	Current