SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AID

Product NDC
85248-164
11-digit product format
852480164
Labeler code
85248
Product ID
85248-164_4d5821f9-605f-5391-e063-6294a90afcd2
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine21mg NICOTINE TRANSDERMAL STOP SMOKING AID
Dosage form
PATCH
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-19
Substance
NICOTINE
Active strength
21 mg/1001
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
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AID
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE21 mg/1001

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
85248-164-01SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AID21 in 1 BOXPATCH211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN4d5821f9-605e-5391-e063-6294a90afcd21
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD4d5821f9-605e-5391-e063-6294a90afcd21
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY4d5821f9-605e-5391-e063-6294a90afcd21
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY4d5821f9-605e-5391-e063-6294a90afcd21
198030nicotine 21 MG/Day 24HR Transdermal SystemSY4d5821f9-605e-5391-e063-6294a90afcd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-164-018524801640121 PATCH in 1 BOX (85248-164-01) 21 patch2026-03-19NoNoCurrent