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 49 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Savvy Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE	Savvy Care and Cosmetics	05ee2662-6a51-6e49-e063-6294a90a4ed7	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Lavender Baby Petroleum	WHITE PETROLEUM	Home Smart Products	5828df37-2a42-4129-8e4e-d5ac9c4c9615	2024-12-19	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	980d030a-feaf-4a81-865e-f85c66151380	2024-12-19	Warnings	Exact identifier application number: M016
Baby Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	caf568aa-3889-41ff-835e-875bb6d9ca79	2024-12-19	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	a45eb8aa-9fc9-4332-a3ef-0e6fd348fb95	2024-12-19	Warnings	Exact identifier application number: M016
Cars Petroleum	WHITE PETROLATUM	Ultra Distributors Inc.	9905b5a4-382e-4d2a-b971-37998c14c330	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Aloe Vera Petroleum	WHITE PETROLEUM	Home Smart Products	2671f2ed-af9d-4234-95bf-def368242a78	2024-12-19	Warnings	Exact identifier application number: M016
DCH Scar	ALLANTOIN 0.5%	Derma Care Research Labs, LLC	00edbc64-9d32-5751-e063-6294a90a400b	2024-12-19	Warnings	Exact identifier application number: M016
Bamboobies Diaper Rash	ZINC OXIDE 15%	Derma Care Research Labs, LLC	0411f5e3-03d2-c512-e063-6394a90a37d3	2024-12-19	Warnings	Exact identifier application number: M016
Maximum Strength Medicated Foot Powder	MEDICATED FOOT POWDER	Jell Pharmaceuticals Pvt. Ltd.	cdaae985-5363-e9d2-e053-2995a90a2682	2024-12-18	Warnings	Exact identifier application number: M016
BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Jell Pharmaceuticals Pvt Ltd.	d80d21cf-9463-7184-e053-2995a90a23f3	2024-12-18	Warnings	Exact identifier application number: M016
Health Smart Baby Petroleum	WHITE PETROLEUM	Home Smart Products	edd9d018-c2c9-4a9a-b727-0a92cd463c02	2024-12-18	Warnings	Exact identifier application number: M016
Health Smart Cocoa Butter Petroleum	WHITE PETROLEUM	Home Smart Products	a65c8267-d34f-4542-a7ca-5180e860a03d	2024-12-18	Warnings	Exact identifier application number: M016
Princess Petroleum	WHITE PETROLATUM	Ultra Distributors Inc.	6d9c92bf-9263-40a4-acac-5c3f0b08c69d	2024-12-18	Warnings	Exact identifier application number: M016
Meijer Petroleum Jelly	WHITE PETROLATUM	Meijer Distribution, Inc	b299cf2a-2c6a-68f4-e053-2995a90a5bd7	2024-12-18	Warnings	Exact identifier application number: M016
Foster and Thrive Caldyphen	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	29945734-4ea6-b702-e063-6294a90ae6f2	2024-12-18	Warnings	Exact identifier application number: M016
Foster and Thrive Caldyphen Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Strategic Sourcing Services, LLC	29946912-9794-8a8e-e063-6394a90a279e	2024-12-18	Warnings	Exact identifier application number: M016
Caring Mills Petroleum Jelly	WHITE PETROLATUM	Veridian Healthcare	fbbfa780-0e2b-1874-e053-6394a90a5eeb	2024-12-18	Warnings	Exact identifier application number: M016
Serawise Eczema Rescue	OATMEAL	DrAnaMaria.com LLC	e805866a-2349-4b86-bc83-a7c859cb9403	2024-12-18	Warnings	Exact identifier application number: M016
TheraCare Petroleum Jelly	WHITE PETROLATUM	Veridian Healthcare	d6fad49b-8a49-7f7c-e053-2a95a90ae638	2024-12-18	Warnings	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