FDA.reportPublic FDA data

NICODERM

Product NDC
0135-0194
11-digit product format
001350194
Labeler code
0135
Product ID
0135-0194_39e81d62-9ad8-8f7f-e063-6394a90a17b2
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Haleon US Holdings LLC
Application
NDA020165
Marketing category
NDA
Marketing start
2011-05-12
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

Additional Listing Data#

Finished product
Yes
Brand name base
NICODERM
Brand name suffix
CQ
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE21 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui198029, 198030, 198031, 351427, 351429, 351433

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
0135-0194-012024-01-30C16284748780-11030e365-53bd-111a-e063-dadaa90a10e2Drug Facts
0135-0194-022024-01-30C16284748780-11030e365-53bd-111a-e063-dadaa90a10e2Drug Facts
0135-0194-032024-01-30C16284748780-11030e365-53bd-111a-e063-dadaa90a10e2Drug Facts
0135-0194-052024-01-30C16284748780-11030e365-53bd-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0194-01NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414
0135-0194-01NICODERMCQ7 in 1 CARTONPATCH, EXTENDED RELEASE714
0135-0194-02NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414
0135-0194-02NICODERMCQ14 in 1 CARTONPATCH, EXTENDED RELEASE1414
0135-0194-03NICODERMCQ1 in 1 PACKAGEPATCH, EXTENDED RELEASE114
0135-0194-03NICODERMCQ21 in 1 CARTONPATCH, EXTENDED RELEASE2114
0135-0194-05NICODERMCQ14 in 1 CARTONPATCH, EXTENDED RELEASE1414
0135-0194-08NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0194-01EA - Each0135-0194764c561d-0286-41c7-8803-a84b913ac63c12012-07-24
0135-0194-02EA - Each0135-0194ed1b78a8-f9d2-4184-9f11-ca2887f2940912012-07-24
0135-0194-03EA - Each0135-01945fa417a3-c62e-4436-bd7b-d75721ec0f5c12014-06-03
0135-0194-05EA - Each0135-0194afb31bf6-e1ae-4c33-83c1-44178201df7512014-06-03
0135-0194-08EA - Each0135-0194e311bc3a-9018-4bab-bf70-37b3e89496e212024-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
NICOTINEACTIVE MOIETY6M3C89ZY6RNICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)INACTIVE INGREDIENTL5F16ZG4ZUNICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7NICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0194NICODERM CQ (NICOTINE) PATCH, EXTENDED RELEASE [HALEON US HOLDINGS LLC]13Current NDC, Legacy NDC, 8 package rows20250519_93b2d1b9-83c1-40b5-b6af-90c38c8d6cef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351429NICODERM CQ (Step 1) 21 MG/Day 24HR Transdermal SystemPSN93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
351427NICODERM CQ (Step 2) 14 MG/Day 24HR Transdermal SystemPSN93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
351433NICODERM CQ (Step 3) 7 MG/Day 24HR Transdermal SystemPSN93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
35143324 HR nicotine 0.292 MG/HR Transdermal System [Nicoderm C-Q]SBD93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
35142724 HR nicotine 0.583 MG/HR Transdermal System [Nicoderm C-Q]SBD93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
35142924 HR nicotine 0.875 MG/HR Transdermal System [Nicoderm C-Q]SBD93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
35143324 HR Nicoderm C-Q 0.292 MG/HR Transdermal SystemSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
35142724 HR Nicoderm C-Q 0.583 MG/HR Transdermal SystemSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
35142924 HR Nicoderm C-Q 0.875 MG/HR Transdermal SystemSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
351433Nicoderm C-Q 0.292 MG/HR 24HR Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
351427Nicoderm C-Q 0.583 MG/HR 24HR Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
351429Nicoderm C-Q 0.875 MG/HR 24HR Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
351429Nicoderm CQ (Step 1) 21 MG/Day 24HR Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
351429NICODERM CQ (Step 1) 21 MG/Day 24HR Transdermal SystemSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
351427Nicoderm CQ (Step 2) 14 MG/Day 24HR Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
351427NICODERM CQ (Step 2) 14 MG/Day 24HR Transdermal SystemSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
351433Nicoderm CQ (Step 3) 7 MG/Day 24HR Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
351433NICODERM CQ (Step 3) 7 MG/Day 24HR Transdermal SystemSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198029nicotine 14 MG/Day 24HR Transdermal SystemSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198030nicotine 21 MG/Day 24HR Transdermal SystemSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14
198031nicotine 7 MG/Day 24HR Transdermal SystemSY93b2d1b9-83c1-40b5-b6af-90c38c8d6cef14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0194-01001350194017 PATCH in 1 CARTON (0135-0194-01) / 24 h in 1 PATCH7 patch2011-05-120000-00-00NoNoCurrent
0135-0194-020013501940214 PATCH in 1 CARTON (0135-0194-02) / 24 h in 1 PATCH14 patch2011-05-120000-00-00NoNoCurrent
0135-0194-03001350194031 CARTON in 1 PACKAGE (0135-0194-03) / 21 PATCH in 1 CARTON / 24 h in 1 PATCH1 carton2011-05-120000-00-00NoNoCurrent
0135-0194-050013501940514 PATCH in 1 CARTON (0135-0194-05) / 24 h in 1 PATCH (0135-0194-08) 14 patch2011-05-120000-00-00NoNoCurrent
0135-0194-080013501940824 h in 1 PATCH24 hHistorical