Nicotine

Product NDC: 55910-313
11-digit product format: 559100313
Labeler code: 55910
Product ID: 55910-313_d5922bcc-4fa7-b82c-1cae-0e49a9a4979a
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: DOLGENCORP, LLC
Application: NDA020076
Marketing category: NDA
Marketing start: 2019-06-15
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: Nicotine
Brand name suffix: transdermal system step 1
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	21 mg/24h

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	6M3C89ZY6R
Rxcui	198030

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55910-313-02	2024-01-30	C162847	48780-1	1030e365-0039-111a-e063-dadaa90a10e2	Nicotine Transdermal patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55910-313-02	Nicotine transdermal system step 1	24 h in 1 PATCH	PATCH, EXTENDED RELEASE	24		8
55910-313-02	Nicotine transdermal system step 1	2 in 1 CARTON	PATCH, EXTENDED RELEASE	2		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-313	NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [DOLGENCORP, LLC]	8	Current NDC, Legacy NDC, 2 package rows	20240726_81e55db2-897e-e567-5743-63179783291a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198030	nicotine 21 MG/Day 24HR Transdermal System	PSN	81e55db2-897e-e567-5743-63179783291a	8
198030	24 HR nicotine 0.875 MG/HR Transdermal System	SCD	81e55db2-897e-e567-5743-63179783291a	8
198030	nicotine 0.875 MG/HR 24HR Transdermal Patch	SY	81e55db2-897e-e567-5743-63179783291a	8
198030	nicotine 21 MG per 24HR 1 Day Transdermal Patch	SY	81e55db2-897e-e567-5743-63179783291a	8
198030	nicotine 21 MG/Day 24HR Transdermal System	SY	81e55db2-897e-e567-5743-63179783291a	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55910-313-02	55910031302	2 PATCH in 1 CARTON (55910-313-02) / 24 h in 1 PATCH	2 patch	2019-06-15	0000-00-00	No	No	Current