FDA.reportPublic FDA data

Signature Care Allergy Relief

Product NDC
21130-089
11-digit product format
211300089
Labeler code
21130
Product ID
21130-089_b5dc04e6-6930-4982-b1bc-094d92f7c238
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Safeway
Application
ANDA207957
Marketing category
ANDA
Marketing start
2016-05-31
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
Signature Care Allergy Relief
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
21130-089-01Signature Care Allergy Relief120 in 1 BOTTLESPRAY, METERED1208
21130-089-01Signature Care Allergy Relief1 in 1 CARTONSPRAY, METERED18
21130-089-02Signature Care Allergy Relief1 in 1 CARTONSPRAY, METERED18
21130-089-02Signature Care Allergy Relief60 in 1 BOTTLESPRAY, METERED608
21130-089-03Signature Care Allergy Relief120 in 1 BOTTLESPRAY, METERED1208
21130-089-03Signature Care Allergy Relief2 in 1 CARTONSPRAY, METERED28
21130-089-08Signature Care Allergy Relief72 in 1 BOTTLESPRAY, METERED728
21130-089-08Signature Care Allergy Relief1 in 1 CARTONSPRAY, METERED18
21130-089-09Signature Care Allergy Relief144 in 1 BOTTLESPRAY, METERED1448
21130-089-09Signature Care Allergy Relief1 in 1 CARTONSPRAY, METERED18
21130-089-10Signature Care Allergy Relief2 in 1 CARTONSPRAY, METERED28
21130-089-10Signature Care Allergy Relief144 in 1 BOTTLESPRAY, METERED1448

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-089SIGNATURE CARE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [SAFEWAY]8Current NDC, Legacy NDC, 12 package rows20221118_59cc17ad-2517-4ff5-8e9a-2a496e707150.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN59cc17ad-2517-4ff5-8e9a-2a496e7071508
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD59cc17ad-2517-4ff5-8e9a-2a496e7071508
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY59cc17ad-2517-4ff5-8e9a-2a496e7071508

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-089-01211300089011 BOTTLE in 1 CARTON (21130-089-01) > 120 SPRAY, METERED in 1 BOTTLE1 bottle2016-05-312023-01-01NoNoCurrent
21130-089-02211300089021 BOTTLE in 1 CARTON (21130-089-02) > 60 SPRAY, METERED in 1 BOTTLE1 bottle2016-08-242023-01-01NoNoCurrent
21130-089-03211300089032 BOTTLE in 1 CARTON (21130-089-03) > 120 SPRAY, METERED in 1 BOTTLE2 bottle2019-04-252023-01-01NoNoCurrent
21130-089-08211300089081 BOTTLE in 1 CARTON (21130-089-08) / 72 SPRAY, METERED in 1 BOTTLE1 bottle2021-06-160000-00-00NoNoCurrent
21130-089-09211300089091 BOTTLE in 1 CARTON (21130-089-09) / 144 SPRAY, METERED in 1 BOTTLE1 bottle2021-06-160000-00-00NoNoCurrent
21130-089-10211300089102 BOTTLE in 1 CARTON (21130-089-10) / 144 SPRAY, METERED in 1 BOTTLE2 bottle2021-06-160000-00-00NoNoCurrent