Pan Aromas Baby

Product NDC: 50346-005
11-digit product format: 503460005
Labeler code: 50346
Product ID: 50346-005_a1ef7014-45b2-408e-8e99-952c0ffbcc27
Type: HUMAN OTC DRUG
Nonproprietary name: Mineral Oil
Dosage form: OIL
Route: TOPICAL
Labeler: Pan Aromas LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-12-20
Marketing end: 0000-00-00
Substance: MINERAL OIL
Active strength: 100 mL/100mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50346-005		I	Inactivated by FDA	2026-11-02
excluded package	package	50346-005	50346-005-16	I	Inactivated by FDA	2026-11-02
excluded package	package	50346-005	50346-005-17	I	Inactivated by FDA	2026-11-02
excluded package	package	50346-005	50346-005-18	I	Inactivated by FDA	2026-11-02
excluded package	package	50346-005	50346-005-19	I	Inactivated by FDA	2026-11-02
excluded package	package	50346-005	50346-005-20	I	Inactivated by FDA	2026-11-02
excluded package	package	50346-005	50346-005-21	I	Inactivated by FDA	2026-11-02
excluded package	package	50346-005	50346-005-22	I	Inactivated by FDA	2026-11-02
excluded package	package	50346-005	50346-005-23	I	Inactivated by FDA	2026-11-02

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 4 · 189 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-005-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-005-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-005-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-005-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-005-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-005-22	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-005-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-005-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-005-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-005-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-005-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-005-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-005-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-005-22	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-005-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-005-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-005-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-005-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-005-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-005-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-005-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-005-22	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-005-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-005-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-005-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-005-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-005-19	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-005-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-005-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-005-22	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-005-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-005-17	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-005-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-005-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-005-19	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-005-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-005-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-005-22	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-005-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-005-17	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-005-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-005-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-005-19	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-005-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-005-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-005-22	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-005-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-005-17	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50346-005-23	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50346-005-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50346-005-19	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50346-005-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50346-005-20	`302b2466d912…`	`e7b80fea0513…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
50346-005-16	cca5a149-01ed-41f8-9cb7-258b94ac94ab
50346-005-17	cca5a149-01ed-41f8-9cb7-258b94ac94ab
50346-005-18	cca5a149-01ed-41f8-9cb7-258b94ac94ab
50346-005-19	cca5a149-01ed-41f8-9cb7-258b94ac94ab
50346-005-20	cca5a149-01ed-41f8-9cb7-258b94ac94ab
50346-005-21	cca5a149-01ed-41f8-9cb7-258b94ac94ab
50346-005-22	cca5a149-01ed-41f8-9cb7-258b94ac94ab
50346-005-23	cca5a149-01ed-41f8-9cb7-258b94ac94ab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50346-005-16	Pan Aromas Baby	100 mL in 1 BOTTLE	OIL	100	1
50346-005-17	Pan Aromas Baby	192 mL in 1 BOTTLE	OIL	192	1
50346-005-18	Pan Aromas Baby	200 mL in 1 BOTTLE	OIL	200	1
50346-005-19	Pan Aromas Baby	296 mL in 1 BOTTLE	OIL	296	1
50346-005-20	Pan Aromas Baby	355 mL in 1 BOTTLE	OIL	355	1
50346-005-21	Pan Aromas Baby	414 mL in 1 BOTTLE	OIL	414	1
50346-005-22	Pan Aromas Baby	474 mL in 1 BOTTLE	OIL	474	1
50346-005-23	Pan Aromas Baby	590 mL in 1 BOTTLE	OIL	590	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	PAN AROMAS BABY (MINERAL OIL) OIL [PAN AROMAS LLC]	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	PAN AROMAS BABY (MINERAL OIL) OIL [PAN AROMAS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50346-005	PAN AROMAS BABY (MINERAL OIL) OIL [PAN AROMAS LLC]	1	Legacy NDC, 8 package rows	20121222_cca5a149-01ed-41f8-9cb7-258b94ac94ab.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1364062	mineral oil 99.9 % Topical Oil	PSN	cca5a149-01ed-41f8-9cb7-258b94ac94ab	1
1364062	mineral oil 999 MG/ML Topical Oil	SCD	cca5a149-01ed-41f8-9cb7-258b94ac94ab	1
1364062	mineral oil 99.9 % Topical Oil	SY	cca5a149-01ed-41f8-9cb7-258b94ac94ab	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50346-005-16	50346000516	100 mL in 1 BOTTLE	100 ml	Historical
50346-005-17	50346000517	192 mL in 1 BOTTLE	192 ml	Historical
50346-005-18	50346000518	200 mL in 1 BOTTLE	200 ml	Historical
50346-005-19	50346000519	296 mL in 1 BOTTLE	296 ml	Historical
50346-005-20	50346000520	355 mL in 1 BOTTLE	355 ml	Historical
50346-005-21	50346000521	414 mL in 1 BOTTLE	414 ml	Historical
50346-005-22	50346000522	474 mL in 1 BOTTLE	474 ml	Historical
50346-005-23	50346000523	590 mL in 1 BOTTLE	590 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pan Aromas Baby - Pan Aromas LLC \| Jell Pharmaceuticals Pvt. Ltd.	Pan Aromas LLC \| Jell Pharmaceuticals Pvt. Ltd.	2012-12-20	HUMAN OTC DRUG LABEL	1