FDA.reportPublic FDA data

CHILDRENS ALLERGY

Product NDC
51316-197
11-digit product format
513160197
Labeler code
51316
Product ID
51316-197_a8280495-9b25-4489-95c2-2e7b55789674
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
ANDA207957
Marketing category
ANDA
Marketing start
2024-06-12
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
51316-197-08CHILDRENS ALLERGY1 in 1 CARTONSPRAY, METERED12
51316-197-08CHILDRENS ALLERGY72 in 1 BOTTLESPRAY, METERED722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-197CHILDRENS ALLERGY (FLUTICASONE PROPIONATE) SPRAY, METERED [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]2Current NDC, 2 package rows20240711_b9b3efe4-2f5c-4d22-80a4-d15fb266fb23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNb9b3efe4-2f5c-4d22-80a4-d15fb266fb232
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDb9b3efe4-2f5c-4d22-80a4-d15fb266fb232
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYb9b3efe4-2f5c-4d22-80a4-d15fb266fb232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-197-08513160197081 BOTTLE in 1 CARTON (51316-197-08) / 72 SPRAY, METERED in 1 BOTTLE1 bottle2024-06-12NoNoCurrent