Jell

Product NDC: 30400-215
11-digit product format: 304000215
Labeler code: 30400
Product ID: 30400-215_54717dd7-c1c4-834a-e063-6394a90adbf2
Type: HUMAN OTC DRUG
Nonproprietary name: Lanolin, Petrolatum
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Jell Pharmaceuticals Pvt Ltd.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-01-12
Substance: PETROLATUM; LANOLIN
Active strength: 53.4; 15.5 g/100g; 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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	30400-215-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	30400-215-20	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	30400-215-40	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	30400-215-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	30400-215-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	30400-215-20	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	30400-215-40	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	30400-215-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	30400-215-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	30400-215-20	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	30400-215-40	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	30400-215-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	30400-215-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	30400-215-20	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	30400-215-40	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	30400-215-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	30400-215-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	30400-215-20	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	30400-215-40	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	30400-215-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	30400-215-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	30400-215-20	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	30400-215-40	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	30400-215-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	30400-215-40	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	30400-215-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	30400-215-10	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	30400-215-20	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	30400-215-40	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	30400-215-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	30400-215-10	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	30400-215-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	30400-215-40	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	30400-215-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	30400-215-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	30400-215-20	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Jell
Brand name suffix: with Vitamin A D
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PETROLATUM	53.4 g/100g
LANOLIN	15.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T6H12BN9U	Internal UNII lookup
7EV65EAW6H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
664981	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
d976e5f0-1be5-d9c4-e053-2a95a90a44a4	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
30400-215-10	Vitamin A & D
30400-215-10	Vitamin A & D
30400-215-20	Vitamin A & D
30400-215-20	Vitamin A & D
30400-215-30	Vitamin A & D
30400-215-30	Vitamin A & D
30400-215-40	Vitamin A & D
30400-215-40	Vitamin A & D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
30400-215-01	Jellwith Vitamin A D	28.3 g in 1 TUBE	OINTMENT	28.3	1
30400-215-02	Jellwith Vitamin A D	56.6 g in 1 TUBE	OINTMENT	56.6	1
30400-215-03	Jellwith Vitamin A D	85 g in 1 TUBE	OINTMENT	85	1
30400-215-04	Jellwith Vitamin A D	113.3 g in 1 TUBE	OINTMENT	113.3	1
30400-215-10	Jellwith Vitamin A D	1 in 1 BOX	OINTMENT	1	1
30400-215-20	Jellwith Vitamin A D	1 in 1 BOX	OINTMENT	1	1
30400-215-30	Jellwith Vitamin A D	1 in 1 BOX	OINTMENT	1	1
30400-215-40	Jellwith Vitamin A D	1 in 1 BOX	OINTMENT	1	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
30400-215	JELL WITH VITAMIN A D (LANOLIN, PETROLATUM) OINTMENT [JELL PHARMACEUTICALS PVT LTD.]	1	Current NDC, Legacy NDC, 8 package rows	20220308_d976e5f0-1be5-d9c4-e053-2a95a90a44a4.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 64 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Itch Relief	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	CVS Pharmacy	c60cfbf2-6788-43dc-b23a-e3433b7f3265	2023-12-20	Warnings	Exact identifier application number: M016
Sunmark Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	c7467f21-56cc-43ca-abfa-e62d35c8baa6	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	08c00c1a-7ec8-4624-9db0-a0e8430cd126	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Caldyphen Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services LLC	329cd4ef-b699-46ff-a5d6-907f7c327c03	2023-12-19	Warnings	Exact identifier application number: M016
DDM Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d536077-b5c6-29b8-e053-2a91aa0a9ae1	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Phenolated Calamine	CALAMINE AND ZINC OXIDE AND PHENOL	Strategic Sourcing Services LLC	8e68efc4-4c95-41c0-9fed-32297b1b2edc	2023-12-19	Warnings	Exact identifier application number: M016
Calm and Heal Melting Balm	ALLANTOIN	The Honest Company, Inc.	b08a1bd6-986d-9520-e053-2995a90a865e	2023-12-19	Warnings	Exact identifier application number: M016
TopCare Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION	TOPCO ASSOCIATES LLC	8dced3ea-147b-3d46-e053-2a95a90aa1c0	2023-12-18	Warnings	Exact identifier application number: M016
TopCare Calamine	CALAMINE 8% AND ZINC OXIDE 8% LOTION	TOPCO ASSOCIATES LLC	8dcf134e-0427-0c43-e053-2995a90a7c26	2023-12-18	Warnings	Exact identifier application number: M016
HEB Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	H E B	5d576794-88d1-484a-e053-2991aa0aa479	2023-12-18	Warnings	Exact identifier application number: M016
Publix Calamine Medicated	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Publix	5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673	2023-12-18	Warnings	Exact identifier application number: M016
TopCare Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	TOPCO ASSOCIATES LLC	8dce8817-b905-4064-e053-2995a90a071e	2023-12-18	Warnings	Exact identifier application number: M016
Assured Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Greenbriar International	9d378cc5-9af0-1389-e053-2995a90a0b96	2023-12-18	Warnings	Exact identifier application number: M016
HEB Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	H E B	5d579680-6bcb-1161-e053-2991aa0aead1	2023-12-18	Warnings	Exact identifier application number: M016
Publix Clear Anti-Itch	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Publix	5d6b905f-ed30-1ab7-e053-2a91aa0a816b	2023-12-18	Warnings	Exact identifier application number: M016
Humco Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Humco Holding Group, Inc.	5fca3a73-6d66-496b-bd33-6e044f9039bc	2023-12-15	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Humco Holding Group, Inc	a3816729-be2b-4b4f-a609-953576cd2e3b	2023-12-15	Warnings	Exact identifier application number: M016
Humco Mineral Oil Light	MINERAL OIL	Humco Holding Group, Inc.	753f35c3-1420-4817-ba63-b737a9c99a1d	2023-12-15	Warnings	Exact identifier application number: M016
Humco Witch Hazel	WITCH HAZEL	Humco Holding Group, Inc.	3cf07016-a129-49ca-8fad-b67dda5aa009	2023-12-15	Warnings	Exact identifier application number: M016
Rite Aid Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Rite Aid Corporation	5df71189-9b36-9dee-e053-2a91aa0a9e49	2023-12-15	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
7EV65EAW6H	LANOLIN	8006-54-0	LANOLIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
664981	lanolin 15.5 % / petrolatum 53.4 % Topical Ointment	PSN	d976e5f0-1be5-d9c4-e053-2a95a90a44a4	1
664981	lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical Ointment	SCD	d976e5f0-1be5-d9c4-e053-2a95a90a44a4	1
664981	lanolin 15.5 % / petrolatum 53.4 % Topical Ointment	SY	d976e5f0-1be5-d9c4-e053-2a95a90a44a4	1
664981	lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical Ointment	SY	d976e5f0-1be5-d9c4-e053-2a95a90a44a4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
30400-215-01	30400021501	28.3 g in 1 TUBE	28.3 g					Historical
30400-215-02	30400021502	56.6 g in 1 TUBE	56.6 g					Historical
30400-215-03	30400021503	85 g in 1 TUBE	85 g					Historical
30400-215-04	30400021504	113.3 g in 1 TUBE	113.3 g					Historical
30400-215-10	30400021510	1 TUBE in 1 BOX (30400-215-10) / 28.3 g in 1 TUBE (30400-215-01)	1 tube	2022-01-12	0000-00-00	No	No	Current
30400-215-20	30400021520	1 TUBE in 1 BOX (30400-215-20) / 56.6 g in 1 TUBE (30400-215-02)	1 tube	2022-01-12	0000-00-00	No	No	Current
30400-215-30	30400021530	1 TUBE in 1 BOX (30400-215-30) / 85 g in 1 TUBE (30400-215-03)	1 tube	2022-01-12	0000-00-00	No	No	Current
30400-215-40	30400021540	1 TUBE in 1 BOX (30400-215-40) / 113.3 g in 1 TUBE (30400-215-04)	1 tube	2022-01-12	0000-00-00	No	No	Current