FDA.reportPublic FDA data

Good Sense 24 hour allergy nasal

Product NDC
0113-0028
11-digit product format
001130028
Labeler code
0113
Product ID
0113-0028_794a1ed4-a0f7-4751-a78b-1400a21869a0
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
L. Perrigo Company
Application
ANDA207957
Marketing category
ANDA
Marketing start
2016-08-03
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense 24 hour allergy nasal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui1797907

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0028-01Good Sense 24 hour allergy nasal1 in 1 CARTONSPRAY, METERED19
0113-0028-01Good Sense 24 hour allergy nasal120 in 1 BOTTLE, SPRAYSPRAY, METERED1209
0113-0028-02Good Sense 24 hour allergy nasal1 in 1 CARTONSPRAY, METERED19
0113-0028-02Good Sense 24 hour allergy nasal60 in 1 BOTTLE, SPRAYSPRAY, METERED609
0113-0028-08Good Sense 24 hour allergy nasal1 in 1 CARTONSPRAY, METERED19
0113-0028-08Good Sense 24 hour allergy nasal72 in 1 BOTTLE, SPRAYSPRAY, METERED729
0113-0028-09Good Sense 24 hour allergy nasal1 in 1 CARTONSPRAY, METERED19
0113-0028-09Good Sense 24 hour allergy nasal144 in 1 BOTTLE, SPRAYSPRAY, METERED1449
0113-0028-11Good Sense 24 hour allergy nasal144 in 1 BOTTLE, SPRAYSPRAY, METERED1449
0113-0028-11Good Sense 24 hour allergy nasal3 in 1 CARTONSPRAY, METERED39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0028-01ML - Milliliter0113-00285aaeda3c-e137-4584-a756-eeff725e03b312021-04-08
0113-0028-02ML - Milliliter0113-0028af1ada3b-64b5-4948-89ba-d63f1bed2d7112021-04-08
0113-0028-09ML - Milliliter0113-00288466bbb5-f4ed-44e7-b5f4-b8d7946f1eaa12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0028GOOD SENSE 24 HOUR ALLERGY NASAL (FLUTICASONE PROPIONATE) SPRAY, METERED [L. PERRIGO COMPANY]7Current NDC, Legacy NDC, 10 package rows20240622_783ce1b9-27e4-428a-9f5e-04e70b234ac9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN783ce1b9-27e4-428a-9f5e-04e70b234ac99
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD783ce1b9-27e4-428a-9f5e-04e70b234ac99
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY783ce1b9-27e4-428a-9f5e-04e70b234ac99
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNf4c26992-c988-e20f-e053-2a95a90afb652
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDf4c26992-c988-e20f-e053-2a95a90afb652
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYf4c26992-c988-e20f-e053-2a95a90afb652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0028-01001130028011 BOTTLE in 1 CARTON (0113-0028-01) > 120 SPRAY, METERED in 1 BOTTLE1 bottle2016-08-030000-00-00NoNoCurrent
0113-0028-02001130028021 BOTTLE in 1 CARTON (0113-0028-02) > 60 SPRAY, METERED in 1 BOTTLE1 bottle2016-08-030000-00-00NoNoCurrent
0113-0028-08001130028081 BOTTLE, SPRAY in 1 CARTON (0113-0028-08) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY2021-02-020000-00-00NoNoCurrent
0113-0028-09001130028091 BOTTLE, SPRAY in 1 CARTON (0113-0028-09) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY2021-06-280000-00-00NoNoCurrent
0113-0028-11001130028113 BOTTLE, SPRAY in 1 CARTON (0113-0028-11) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY2026-01-29NoNoCurrent