FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui1797886, 1797888

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
0009-5401-01Nicotrol4 in 1 BOXSPRAY, METERED419
0009-5401-01Nicotrol10 mL in 1 BOTTLE, SPRAYSPRAY, METERED1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-5401-01ML - Milliliter0009-54014f7f594c-6d88-4f66-b40a-3d50384128c212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]8
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]8
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]8
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]8
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]8
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]8
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]8
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWNICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]8
WATERINACTIVE INGREDIENT059QF0KO0RNICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA AND UPJOHN COMPANY]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-5401NICOTROL (NICOTINE) SPRAY, METERED [PHARMACIA & UPJOHN COMPANY LLC]18Current NDC, Legacy NDC, 2 package rows20240620_acb7d02d-249b-4645-ac1b-8ff9a56dd244.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797886nicotine 0.5 MG/ACTUAT Metered Dose Nasal SprayPSNacb7d02d-249b-4645-ac1b-8ff9a56dd24419
1797888Nicotrol 0.5 MG/ACTUAT Metered Dose Nasal SprayPSNacb7d02d-249b-4645-ac1b-8ff9a56dd24419
1797888nicotine 0.5 MG/ACTUAT Metered Dose Nasal Spray [Nicotrol]SBDacb7d02d-249b-4645-ac1b-8ff9a56dd24419
1797886nicotine 0.5 MG/ACTUAT Metered Dose Nasal SpraySCDacb7d02d-249b-4645-ac1b-8ff9a56dd24419
1797888Nicotrol 0.5 MG/ACTUAT Metered Dose Nasal SpraySYacb7d02d-249b-4645-ac1b-8ff9a56dd24419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0009-5401-01000095401014 BOTTLE, SPRAY in 1 BOX (0009-5401-01) / 10 mL in 1 BOTTLE, SPRAY1996-05-220000-00-00NoNoCurrent