Nicotine

Product NDC
68196-194
11-digit product format
681960194
Labeler code
68196
Product ID
68196-194_0688260f-58f8-41f6-8b77-4e16833f58cc
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Sam's West Inc
Application
NDA020165
Marketing category
NDA
Marketing start
2012-03-02
Substance
NICOTINE
Active strength
21 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68196-19468196-194-03DDiscontinued by firm2026-08-03

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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68196-194-03DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68196-194-03DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68196-194-03IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68196-194-03IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68196-194-03IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68196-194-03IInactivated by FDA8dfbde2a14a4…c9ff85d89658…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020165-004NICODERM CQNICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02
N020165-005NICODERM CQNICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02
N020165-006NICODERM CQNICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-028072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020165-00492050592019-12-15Drug product2016-01-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00486636802020-02-13Drug product2014-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00489993792020-02-13U-16862015-05-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00480759112021-05-22Drug product2012-03-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00592050592019-12-15Drug product2016-01-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00586636802020-02-13Drug product2014-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00589993792020-02-13U-16862015-05-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00580759112021-05-22Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00692050592019-12-15Drug product2016-01-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00686636802020-02-13Drug product2014-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00689993792020-02-13U-16862015-05-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00680759112021-05-22Drug product74a2ff9319b5…
2021-12-28 21:50 UTC2021-12N020165-00480759112021-05-22Drug product2012-03-09782e0a99824c…
2021-12-28 21:50 UTC2021-12N020165-00580759112021-05-22Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N020165-00680759112021-05-22Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020165-00480759112021-05-22Drug product2012-03-0987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020165-00580759112021-05-22Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020165-00680759112021-05-22Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N020165-00480759112021-05-22Drug product2012-03-095aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020165-00580759112021-05-22Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020165-00680759112021-05-22Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020165-00486636802020-02-13Drug product2014-03-318869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00489993792020-02-13U-16862015-05-048869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00480759112021-05-22Drug product2012-03-098869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00586636802020-02-13Drug product2014-03-318869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00589993792020-02-13U-16862015-05-048869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00580759112021-05-22Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00686636802020-02-13Drug product2014-03-318869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00689993792020-02-13U-16862015-05-048869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00680759112021-05-22Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020165-00486636802020-02-13Drug product2014-03-31c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00489993792020-02-13U-16862015-05-04c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00480759112021-05-22Drug product2012-03-09c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00586636802020-02-13Drug product2014-03-31c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00589993792020-02-13U-16862015-05-04c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00580759112021-05-22Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00686636802020-02-13Drug product2014-03-31c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00689993792020-02-13U-16862015-05-04c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00680759112021-05-22Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N020165-00492050592019-12-15Drug product2016-01-063f01610625f2…

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Brand name suffix
transdermal system
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE21 mg/24h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M3C89ZY6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198030Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-03-21Drug Facts
2024-01-30Drug Facts
2022-07-15Drug Facts
2021-01-29Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-194-03Nicotinetransdermal system21 in 1 CARTONPATCH, EXTENDED RELEASE2110
68196-194-03Nicotinetransdermal system24 h in 1 PATCHPATCH, EXTENDED RELEASE2410

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [SAM'S WEST INC]4
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [SAM'S WEST INC]4
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)INACTIVE INGREDIENTL5F16ZG4ZUNICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [SAM'S WEST INC]4
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [SAM'S WEST INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-194NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [SAM'S WEST INC]9Current NDC, Legacy NDC, 2 package rows20240322_cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine transdermal systemNICOTINEWal-Mart Stores Incaefd30c4-35d5-425e-855c-327a7c4361882026-01-26WarningsExact identifier
application applno (NDA): 020165
application number: NDA020165
NICODERM CQNICOTINEHaleon US Holdings LLC93b2d1b9-83c1-40b5-b6af-90c38c8d6cef2025-07-14WarningsExact identifier
application applno (NDA): 020165
application number: NDA020165
Nicotine transdermal systemNICOTINESam's West Inccd9aa56c-ac88-4f9b-9ff9-a9720af6c1a72025-06-10WarningsExact identifier
application applno (NDA): 020165
application number: NDA020165
ndc (product): 68196-194
Nicotine transdermal systemNICOTINETarget Corporationf8d6bf61-6d66-4651-8145-c4cb1d5e443f2025-06-10WarningsExact identifier
application applno (NDA): 020165
application number: NDA020165

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNcd9aa56c-ac88-4f9b-9ff9-a9720af6c1a710
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDcd9aa56c-ac88-4f9b-9ff9-a9720af6c1a710
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYcd9aa56c-ac88-4f9b-9ff9-a9720af6c1a710
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYcd9aa56c-ac88-4f9b-9ff9-a9720af6c1a710
198030nicotine 21 MG/Day 24HR Transdermal SystemSYcd9aa56c-ac88-4f9b-9ff9-a9720af6c1a710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-194-036819601940321 PATCH in 1 CARTON (68196-194-03) > 24 h in 1 PATCH21 patch2012-03-020000-00-00NoNoCurrent