Nicotine Patches

Product NDC
85333-003
11-digit product format
853330003
Labeler code
85333
Product ID
85333-003_4c1d00b3-313c-933f-e063-6294a90ac46f
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Patches
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Zhejiang FTA Shengzuozhi Biotechnology Co., LTD
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-03
Substance
NICOTINE
Active strength
21 mg/21mg
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Patches
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE21 mg/21mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui198030

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85333-003-02Nicotine Patches21 mg in 1 PATCHPATCH211
85333-003-02Nicotine Patches14 in 1 BOXPATCH141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN4c1d00b3-313b-933f-e063-6294a90ac46f1
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD4c1d00b3-313b-933f-e063-6294a90ac46f1
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY4c1d00b3-313b-933f-e063-6294a90ac46f1
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY4c1d00b3-313b-933f-e063-6294a90ac46f1
198030nicotine 21 MG/Day 24HR Transdermal SystemSY4c1d00b3-313b-933f-e063-6294a90ac46f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85333-003-028533300030214 PATCH in 1 BOX (85333-003-02) / 21 mg in 1 PATCH14 patch2026-03-03NoNoCurrent