Nicotine

Product NDC
11822-4973
11-digit product format
118224973
Labeler code
11822
Product ID
11822-4973_31036926-dedd-9ff4-05eb-ebc5a28af900
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Rite Aid Corporation
Application
NDA020076
Marketing category
NDA
Marketing start
2015-05-14
Substance
NICOTINE
Active strength
7 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020076-004HABITROLNICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-005HABITROLNICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-006HABITROLNICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine transdermal system step 3NICOTINERite Aid Corporationd2e32434-ec58-943e-dbeb-8e73315315952024-07-26WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Ask a doctor before use if you have heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. an allergy to adhesive tape or have skin problems, because you are more likely to get rashes. stomach ulcer or diabetes. history of seizures. Ask a doctor or pharmacist before use if you are • using a non-nicotine stop smoking drug • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. When using this product • if you have vivid dreams or other sleep disturbances remove this patch at bedtime Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash. irregular heartbeat or palpitations occur. you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeat. you have symptoms of an allergic reaction (such as difficulty breathing or rash). Keep out of reach of children and pets. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Brand name suffix
transdermal system step 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE7 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui198029, 198030, 198031

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4973NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [RITE AID CORPORATION]7Current NDC, Legacy NDC20240727_d2e32434-ec58-943e-dbeb-8e7331531595.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNd2e32434-ec58-943e-dbeb-8e73315315957
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNd2e32434-ec58-943e-dbeb-8e73315315957
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNd2e32434-ec58-943e-dbeb-8e73315315957
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDd2e32434-ec58-943e-dbeb-8e73315315957
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDd2e32434-ec58-943e-dbeb-8e73315315957
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDd2e32434-ec58-943e-dbeb-8e73315315957
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198029nicotine 14 MG/Day 24HR Transdermal SystemSYd2e32434-ec58-943e-dbeb-8e73315315957
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198030nicotine 21 MG/Day 24HR Transdermal SystemSYd2e32434-ec58-943e-dbeb-8e73315315957
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYd2e32434-ec58-943e-dbeb-8e73315315957
198031nicotine 7 MG/Day 24HR Transdermal SystemSYd2e32434-ec58-943e-dbeb-8e73315315957

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-4973-01182249730014 PATCH in 1 CARTON (11822-4973-0) / 24 h in 1 PATCH14 patch2015-05-140000-00-00NoNoCurrent