NICORETTE

Product NDC: 0135-0509
11-digit product format: 001350509
Labeler code: 0135
Product ID: 0135-0509_b26eda42-5df1-45b9-bab1-f1c557a2bad1
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application: NDA022360
Marketing category: NDA
Marketing start: 2010-03-01
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 4 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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	0135-0509		D	Discontinued by firm	2026-08-07
excluded package	package	0135-0509	0135-0509-02	D	Discontinued by firm	2026-08-07
excluded package	package	0135-0509	0135-0509-03	D	Discontinued by firm	2026-08-07
excluded package	package	0135-0509	0135-0509-04	D	Discontinued by firm	2026-08-07

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 · 48 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0135-0509-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0135-0509-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0135-0509-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0135-0509-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0135-0509-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0135-0509-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0135-0509-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0135-0509-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0135-0509-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0135-0509-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0135-0509-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0135-0509-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0135-0509-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0135-0509-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0135-0509-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0135-0509-03	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0135-0509-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0135-0509-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0135-0509-03	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0135-0509-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0135-0509-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0135-0509-03	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0135-0509-04	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0135-0509-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0135-0509-03	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0135-0509-04	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0135-0509-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0135-0509-03	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0135-0509-04	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0135-0509-02	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0135-0509-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0135-0509-04	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0135-0509-02	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0135-0509-03	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0135-0509-02	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0135-0509-04	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022360-001	NICORETTE	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL		RLD	2009-05-18
N022360-002	NICORETTE	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL		RLD, RS	2009-05-18

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022360-001	8940772	2029-04-30	Drug product	2015-02-25
N022360-001	8501164	2029-06-14	Drug product	2013-09-05
N022360-002	8940772	2029-04-30	Drug product	2015-02-25
N022360-002	8501164	2029-06-14	Drug product	2013-09-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022360-001	NICORETTE	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	RLD	2009-05-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022360-002	NICORETTE	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	RLD, RS	2009-05-18	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022360-001	8940772	2029-04-30	Drug product	2015-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022360-001	8501164	2029-06-14	Drug product	2013-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022360-002	8940772	2029-04-30	Drug product	2015-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022360-002	8501164	2029-06-14	Drug product	2013-09-05	`d06236e962d9…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0135-0509-02	2023-11-02	Drug Facts
0135-0509-03	2023-11-02	Drug Facts
0135-0509-04	2023-11-02	Drug Facts
0135-0509-02	2023-01-30	Drug Facts
0135-0509-03	2023-01-30	Drug Facts
0135-0509-04	2023-01-30	Drug Facts
0135-0509-02	2020-10-20	Drug Facts
0135-0509-03	2020-10-20	Drug Facts
0135-0509-04	2020-10-20	Drug Facts
0135-0509-02	2020-01-31	Drug Facts
0135-0509-03	2020-01-31	Drug Facts
0135-0509-04	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0509-02	NICORETTE	3 in 1 CARTON	LOZENGE	3	15
0135-0509-02	NICORETTE	27 in 1 CONTAINER	LOZENGE	27	15
0135-0509-03	NICORETTE	5 in 1 CARTON	LOZENGE	5	15
0135-0509-03	NICORETTE	27 in 1 CONTAINER	LOZENGE	27	15
0135-0509-04	NICORETTE	20 in 1 CONTAINER	LOZENGE	20	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0509-02	EA - Each	0135-0509	f97c9b19-e284-4eed-9dac-a897df1f14f4	1	2012-07-24
0135-0509-03	EA - Each	0135-0509	aecea704-a2c0-46f9-834e-464df19a3336	1	2012-07-24
0135-0509-04	EA - Each	0135-0509	06cf46ae-b1f7-4224-9c7c-d9935cb04318	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	9
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	9
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	9
CALCIUM POLYCARBOPHIL	INACTIVE INGREDIENT	8F049NKY49	NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	9
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	9
POLACRILIN	INACTIVE INGREDIENT	RCZ785HI7S	NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	9
POTASSIUM BICARBONATE	INACTIVE INGREDIENT	HM5Z15LEBN	NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	9
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	9
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	9
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0509	NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC]	15	Legacy NDC, 5 package rows	20240307_fdee1637-8049-4bc5-b196-b6d854c9f9f3.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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicorette Peppermint	NICOTINE POLACRILEX	Haleon US Holdings LLC	990a4a65-d573-46a9-889d-60afb0018944	2025-07-31	Warnings	Exact identifier application applno (NDA): 022360 application number: NDA022360
Nicorette Cherry Peppermint	NICOTINE POLACRILEX	Haleon US Holdings LLC	35438b53-2760-bcfe-e063-6394a90a65c0	2025-06-09	Warnings	Exact identifier application applno (NDA): 022360 application number: NDA022360
NICORETTE	NICOTINE POLACRILEX	Haleon US Holdings LLC	c7f32ab1-f6bd-46f5-9852-8eb5b78a3326	2025-04-25	Warnings	Exact identifier application applno (NDA): 022360 application number: NDA022360
NICORETTE	NICOTINE POLACRILEX	Haleon US Holdings LLC	fdee1637-8049-4bc5-b196-b6d854c9f9f3	2024-03-05	Warnings	Exact identifier application applno (NDA): 022360 application number: NDA022360 ndc (product): 0135-0509

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M3C89ZY6R	NICOTINE	54-11-5	NICOTINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
968849	Nicorette 2 MG Oral Lozenge	PSN	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
968851	Nicorette 4 MG Oral Lozenge	PSN	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
359817	nicotine 2 MG Oral Lozenge	PSN	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
359818	nicotine 4 MG Oral Lozenge	PSN	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
968849	nicotine 2 MG Oral Lozenge [Nicorette]	SBD	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
968851	nicotine 4 MG Oral Lozenge [Nicorette]	SBD	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
359817	nicotine 2 MG Oral Lozenge	SCD	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
359818	nicotine 4 MG Oral Lozenge	SCD	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
968849	Nicorette 2 MG (nicotine polacrilex 11.1 MG) Oral Lozenge	SY	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
968849	Nicorette 2 MG Oral Lozenge	SY	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
968849	Nicorette 2 MG Troche	SY	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
968851	Nicorette 4 MG (nicotine polacrilex 22.2 MG) Oral Lozenge	SY	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
968851	Nicorette 4 MG Oral Lozenge	SY	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
359817	nicotine 2 MG Troche	SY	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15
359818	nicotine 4 MG Troche	SY	fdee1637-8049-4bc5-b196-b6d854c9f9f3	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0509-02	00135050902	3 CONTAINER in 1 CARTON (0135-0509-02) > 27 LOZENGE in 1 CONTAINER	3 container	2010-03-01	0000-00-00	No	No	Current
0135-0509-03	00135050903	5 CONTAINER in 1 CARTON (0135-0509-03) > 27 LOZENGE in 1 CONTAINER	5 container	2010-03-01	0000-00-00	No	No	Current
0135-0509-04	00135050904	20 LOZENGE in 1 CONTAINER (0135-0509-04)	20 lozenge	2010-03-01	0000-00-00	No	No	Current