FDA.reportPublic FDA data

Childrens Nasonex

Product NDC
0113-1999
11-digit product format
001131999
Labeler code
0113
Product ID
0113-1999_f6160235-eaca-44be-9adb-757436243b72
Type
HUMAN OTC DRUG
Nonproprietary name
mometasone furoate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
L. Perrigo Company
Application
NDA215712
Marketing category
NDA
Marketing start
2023-02-07
Substance
MOMETASONE FUROATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], 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 Nasonex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04201GDN4R
Rxcui1797865, 1797870

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
ce567bde-218c-2386-f79b-42addb0c34fbProduct name220180829
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4Product name120180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1dProduct name220170613
511188c3-b8c1-4966-aa31-5463cfd4fa48Product name120141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070Product name120140508
aca60174-7f12-2753-ec74-0eb827cf0776Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-1999-01Childrens Nasonex30 in 1 BOTTLE, SPRAYSPRAY, METERED303
0113-1999-01Childrens Nasonex1 in 1 PACKAGESPRAY, METERED13
0113-1999-11Childrens Nasonex60 in 1 BOTTLE, SPRAYSPRAY, METERED603
0113-1999-11Childrens Nasonex1 in 1 PACKAGESPRAY, METERED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-1999-01ML - Milliliter0113-19990935bdff-7ca7-449d-81f2-e5c2aa91738812024-02-14
0113-1999-11ML - Milliliter0113-1999ac9d5f71-4a1e-4d92-b794-4ae039dbbdb212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1999CHILDRENS NASONEX (MOMETASONE FUROATE) SPRAY, METERED [L. PERRIGO COMPANY]3Current NDC, 4 package rows20240906_e15d055e-9a25-46b4-8724-3609cf2dc062.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNe15d055e-9a25-46b4-8724-3609cf2dc0623
1797870NASONEX 50 MCG/ACTUAT Metered Dose Nasal SprayPSNe15d055e-9a25-46b4-8724-3609cf2dc0623
1797870mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Nasonex]SBDe15d055e-9a25-46b4-8724-3609cf2dc0623
1797865mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDe15d055e-9a25-46b4-8724-3609cf2dc0623
1797865mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal SpraySYe15d055e-9a25-46b4-8724-3609cf2dc0623
1797870Nasonex 0.05 MG/ACTUAT Metered Dose Nasal SpraySYe15d055e-9a25-46b4-8724-3609cf2dc0623
1797870Nasonex 50 MCG/ACTUAT Metered Dose Nasal SpraySYe15d055e-9a25-46b4-8724-3609cf2dc0623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0113-1999-01001131999011 BOTTLE, SPRAY in 1 PACKAGE (0113-1999-01) / 30 SPRAY, METERED in 1 BOTTLE, SPRAY2023-03-15NoNoHistorical
0113-1999-11001131999111 BOTTLE, SPRAY in 1 PACKAGE (0113-1999-11) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY2023-02-07NoNoHistorical