Nicotine

Product NDC
49035-195
11-digit product format
490350195
Labeler code
49035
Product ID
49035-195_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
14 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE14 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198029Internal RxNorm lookup
198030Internal RxNorm lookup
198031Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aefd30c4-35d5-425e-855c-327a7c436188Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-195-022021-12-16C16284748780-1ba0f9c33-386a-a910-e053-dadaa90a0b85Drug Facts
49035-195-022021-01-29C16284748780-1ba0f9c33-386a-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-195-02Nicotinetransdermal system14 in 1 CARTONPATCH, EXTENDED RELEASE1415
49035-195-02Nicotinetransdermal system24 h in 1 PATCHPATCH, EXTENDED RELEASE2415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-195-02EA - Each49035-1958f181161-0a70-4fea-ab7e-6fe817372d1e12013-07-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-195NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [WAL-MART STORES INC]14Current NDC, Legacy NDC, 2 package rows20241220_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
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
ndc (product): 49035-195
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
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
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNaefd30c4-35d5-425e-855c-327a7c43618815
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNaefd30c4-35d5-425e-855c-327a7c43618815
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNaefd30c4-35d5-425e-855c-327a7c43618815
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDaefd30c4-35d5-425e-855c-327a7c43618815
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDaefd30c4-35d5-425e-855c-327a7c43618815
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDaefd30c4-35d5-425e-855c-327a7c43618815
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198029nicotine 14 MG/Day 24HR Transdermal SystemSYaefd30c4-35d5-425e-855c-327a7c43618815
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198030nicotine 21 MG/Day 24HR Transdermal SystemSYaefd30c4-35d5-425e-855c-327a7c43618815
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198031nicotine 7 MG/Day 24HR Transdermal SystemSYaefd30c4-35d5-425e-855c-327a7c43618815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-195-024903501950214 PATCH in 1 CARTON (49035-195-02) / 24 h in 1 PATCH14 patch2010-10-190000-00-00NoNoCurrent