Nicotine

Product NDC: 49035-194
11-digit product format: 490350194
Labeler code: 49035
Product ID: 49035-194_085e5042-be1f-49ea-88a8-804fc969824f
Type: HUMAN OTC DRUG
Nonproprietary name: nicotine
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Wal-Mart Stores Inc
Application: NDA020165
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2010-10-19
Substance: NICOTINE
Active strength: 21 mg/24h
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49035-194		D	Discontinued by firm		2026-08-03
excluded package	package	49035-194	49035-194-72	D	Discontinued by firm		2026-08-03

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 · 24 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	49035-194-72	`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	49035-194-72	`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	49035-194-72	`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	49035-194-72	`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	49035-194-72	`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	49035-194-72	`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	49035-194-72	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49035-194-72	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49035-194-72	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49035-194-72	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49035-194-72	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49035-194-72	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020165-004	NICODERM CQ	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02
N020165-005	NICODERM CQ	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02
N020165-006	NICODERM CQ	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02

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 4 · 123 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	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020165-005	NICODERM CQ	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020165-006	NICODERM CQ	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1996-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020165-004	NICODERM CQ	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1996-08-02	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020165-004	9205059	2019-12-15		Drug product	2016-01-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-004	8663680	2020-02-13		Drug product	2014-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-004	8999379	2020-02-13	U-1686		2015-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-005	9205059	2019-12-15		Drug product	2016-01-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-005	8663680	2020-02-13		Drug product	2014-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-005	8999379	2020-02-13	U-1686		2015-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-005	8075911	2021-05-22		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-006	9205059	2019-12-15		Drug product	2016-01-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-006	8663680	2020-02-13		Drug product	2014-03-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-006	8999379	2020-02-13	U-1686		2015-05-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020165-006	8075911	2021-05-22		Drug product		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020165-005	8075911	2021-05-22		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020165-006	8075911	2021-05-22		Drug product		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020165-005	8075911	2021-05-22		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020165-006	8075911	2021-05-22		Drug product		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020165-005	8075911	2021-05-22		Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020165-006	8075911	2021-05-22		Drug product		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020165-004	8663680	2020-02-13		Drug product	2014-03-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-004	8999379	2020-02-13	U-1686		2015-05-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-005	8663680	2020-02-13		Drug product	2014-03-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-005	8999379	2020-02-13	U-1686		2015-05-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-005	8075911	2021-05-22		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-006	8663680	2020-02-13		Drug product	2014-03-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-006	8999379	2020-02-13	U-1686		2015-05-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020165-006	8075911	2021-05-22		Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020165-004	8663680	2020-02-13		Drug product	2014-03-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-004	8999379	2020-02-13	U-1686		2015-05-04	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-004	8075911	2021-05-22		Drug product	2012-03-09	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-005	8663680	2020-02-13		Drug product	2014-03-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-005	8999379	2020-02-13	U-1686		2015-05-04	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-005	8075911	2021-05-22		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-006	8663680	2020-02-13		Drug product	2014-03-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-006	8999379	2020-02-13	U-1686		2015-05-04	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020165-006	8075911	2021-05-22		Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020165-004	9205059	2019-12-15		Drug product	2016-01-06	`3f01610625f2…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotine
Brand name suffix: transdermal system
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	21 mg/24h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6M3C89ZY6R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198029	Internal RxNorm lookup
198030	Internal RxNorm lookup
198031	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
aefd30c4-35d5-425e-855c-327a7c436188	Available on FDA.report

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
49035-194-01	2021-12-16	Drug Facts
49035-194-02	2021-12-16	Drug Facts
49035-194-01	2021-01-29	Drug Facts
49035-194-02	2021-01-29	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49035-194-01	Nicotinetransdermal system	7 in 1 CARTON	PATCH, EXTENDED RELEASE	7	15
49035-194-01	Nicotinetransdermal system	24 h in 1 PATCH	PATCH, EXTENDED RELEASE	24	15
49035-194-02	Nicotinetransdermal system	14 in 1 CARTON	PATCH, EXTENDED RELEASE	14	15
49035-194-02	Nicotinetransdermal system	24 h in 1 PATCH	PATCH, EXTENDED RELEASE	24	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-194-01	EA - Each	49035-194	1822c446-eb6a-4fa5-9fc3-4e2f2b4b4982	1	2013-02-13
49035-194-02	EA - Each	49035-194	11f4038f-fa4d-41d3-aa07-6d0ec0a4f27a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [WAL-MART STORES INC]	6
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [WAL-MART STORES INC]	6
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)	INACTIVE INGREDIENT	L5F16ZG4ZU	NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [WAL-MART STORES INC]	6
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [WAL-MART STORES INC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-194	NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [WAL-MART STORES INC]	14	Current NDC, Legacy NDC, 4 package rows	20241220_aefd30c4-35d5-425e-855c-327a7c436188.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
Nicotine transdermal system	NICOTINE	Wal-Mart Stores Inc	aefd30c4-35d5-425e-855c-327a7c436188	2026-01-26	Warnings	Exact identifier application applno (NDA): 020165 application number: NDA020165 ndc (product): 49035-194
NICODERM CQ	NICOTINE	Haleon US Holdings LLC	93b2d1b9-83c1-40b5-b6af-90c38c8d6cef	2025-07-14	Warnings	Exact identifier application applno (NDA): 020165 application number: NDA020165
Nicotine transdermal system	NICOTINE	Sam's West Inc	cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7	2025-06-10	Warnings	Exact identifier application applno (NDA): 020165 application number: NDA020165
Nicotine transdermal system	NICOTINE	Target Corporation	f8d6bf61-6d66-4651-8145-c4cb1d5e443f	2025-06-10	Warnings	Exact identifier application applno (NDA): 020165 application number: NDA020165

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
198029	nicotine 14 MG/Day 24HR Transdermal System	PSN	aefd30c4-35d5-425e-855c-327a7c436188	15
198030	nicotine 21 MG/Day 24HR Transdermal System	PSN	aefd30c4-35d5-425e-855c-327a7c436188	15
198031	nicotine 7 MG/Day 24HR Transdermal System	PSN	aefd30c4-35d5-425e-855c-327a7c436188	15
198031	24 HR nicotine 0.292 MG/HR Transdermal System	SCD	aefd30c4-35d5-425e-855c-327a7c436188	15
198029	24 HR nicotine 0.583 MG/HR Transdermal System	SCD	aefd30c4-35d5-425e-855c-327a7c436188	15
198030	24 HR nicotine 0.875 MG/HR Transdermal System	SCD	aefd30c4-35d5-425e-855c-327a7c436188	15
198031	nicotine 0.292 MG/HR 24HR Transdermal Patch	SY	aefd30c4-35d5-425e-855c-327a7c436188	15
198029	nicotine 0.583 MG/HR 24HR Transdermal Patch	SY	aefd30c4-35d5-425e-855c-327a7c436188	15
198030	nicotine 0.875 MG/HR 24HR Transdermal Patch	SY	aefd30c4-35d5-425e-855c-327a7c436188	15
198029	nicotine 14 MG per 24HR 1 Day Transdermal Patch	SY	aefd30c4-35d5-425e-855c-327a7c436188	15
198029	nicotine 14 MG/Day 24HR Transdermal System	SY	aefd30c4-35d5-425e-855c-327a7c436188	15
198030	nicotine 21 MG per 24HR 1 Day Transdermal Patch	SY	aefd30c4-35d5-425e-855c-327a7c436188	15
198030	nicotine 21 MG/Day 24HR Transdermal System	SY	aefd30c4-35d5-425e-855c-327a7c436188	15
198031	nicotine 7 MG per 24HR 1 Day Transdermal Patch	SY	aefd30c4-35d5-425e-855c-327a7c436188	15
198031	nicotine 7 MG/Day 24HR Transdermal System	SY	aefd30c4-35d5-425e-855c-327a7c436188	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-194-01	49035019401	7 PATCH in 1 CARTON (49035-194-01) / 24 h in 1 PATCH	7 patch	2010-10-19	0000-00-00	No	No	Current
49035-194-02	49035019402	14 PATCH in 1 CARTON (49035-194-02) / 24 h in 1 PATCH	14 patch	2010-10-19	0000-00-00	No	No	Current