Nicotrol

Product NDC: 0009-5401
11-digit product format: 000095401
Labeler code: 0009
Product ID: 0009-5401_33997044-c41d-481b-b724-15463f892bd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nicotine
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA020385
Marketing category: NDA
Marketing start: 1996-05-22
Substance: NICOTINE
Active strength: 10 mg/mL
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020385-001	NICOTROL	NICOTINE	0.5MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	1996-03-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020385-001	NICOTROL	0.5MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	1996-03-22	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotrol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6M3C89ZY6R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1797886	Internal RxNorm lookup
1797888	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
acb7d02d-249b-4645-ac1b-8ff9a56dd244	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0009-5401-01	Nicotrol	4 in 1 BOX	SPRAY, METERED	4		19
0009-5401-01	Nicotrol	10 mL in 1 BOTTLE, SPRAY	SPRAY, METERED	10		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-5401-01	ML - Milliliter	0009-5401	4f7f594c-6d88-4f66-b40a-3d50384128c2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]	8
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]	8
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]	8
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]	8
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]	8
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]	8
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]	8
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]	8
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-5401	NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA & UPJOHN COMPANY LLC]	18	Current NDC, Legacy NDC, 2 package rows	20240620_acb7d02d-249b-4645-ac1b-8ff9a56dd244.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotrol	NICOTINE	Pharmacia & Upjohn Company LLC	acb7d02d-249b-4645-ac1b-8ff9a56dd244	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020385 application number: NDA020385 ndc (product): 0009-5401

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M3C89ZY6R	NICOTINE	54-11-5	NICOTINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1797886	nicotine 0.5 MG/ACTUAT Metered Dose Nasal Spray	PSN	acb7d02d-249b-4645-ac1b-8ff9a56dd244	19
1797888	Nicotrol 0.5 MG/ACTUAT Metered Dose Nasal Spray	PSN	acb7d02d-249b-4645-ac1b-8ff9a56dd244	19
1797888	nicotine 0.5 MG/ACTUAT Metered Dose Nasal Spray [Nicotrol]	SBD	acb7d02d-249b-4645-ac1b-8ff9a56dd244	19
1797886	nicotine 0.5 MG/ACTUAT Metered Dose Nasal Spray	SCD	acb7d02d-249b-4645-ac1b-8ff9a56dd244	19
1797888	Nicotrol 0.5 MG/ACTUAT Metered Dose Nasal Spray	SY	acb7d02d-249b-4645-ac1b-8ff9a56dd244	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-5401-01	00009540101	4 BOTTLE, SPRAY in 1 BOX (0009-5401-01) / 10 mL in 1 BOTTLE, SPRAY	1996-05-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotrol ® NS (nicotine nasal spray)	Pharmacia & Upjohn Company LLC	2025-05-29	HUMAN PRESCRIPTION DRUG LABEL	19