topcare allergy

Product NDC: 76162-134
11-digit product format: 761620134
Labeler code: 76162
Product ID: 76162-134_1396fed3-16fb-421a-89c5-4dd83706cd41
Type: HUMAN OTC DRUG
Nonproprietary name: mometasone furoate monohydrate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Topco Associates LLC
Application: NDA215712
Marketing category: NDA
Marketing start: 2023-03-28
Substance: MOMETASONE FUROATE MONOHYDRATE
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215712-001	NASONEX 24HR ALLERGY	MOMETASONE FUROATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2022-03-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215712-001	NASONEX 24HR ALLERGY	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2022-03-17	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: topcare allergy
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MOMETASONE FUROATE MONOHYDRATE	50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MTW0WEG809	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1797865	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9e7c759e-d2cb-4505-ad9f-38efaaaeefc2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
624001e0-0eba-4aac-a60c-c2ecb37d4f08	Product name	1	20220927
1cbe9071-502b-482d-9c24-839b43446576	Product name	1	20200123
ce567bde-218c-2386-f79b-42addb0c34fb	Product name	2	20180829
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4	Product name	1	20180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1d	Product name	2	20170613
511188c3-b8c1-4966-aa31-5463cfd4fa48	Product name	1	20141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070	Product name	1	20140508
aca60174-7f12-2753-ec74-0eb827cf0776	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76162-134-02	topcare allergy	1 in 1 CARTON	SPRAY, METERED	1	4
76162-134-02	topcare allergy	120 in 1 BOTTLE, SPRAY	SPRAY, METERED	120	4
76162-134-11	topcare allergy	60 in 1 BOTTLE, SPRAY	SPRAY, METERED	60	4
76162-134-11	topcare allergy	1 in 1 CARTON	SPRAY, METERED	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76162-134	TOPCARE ALLERGY (MOMETASONE FUROATE MONOHYDRATE) SPRAY, METERED [TOPCO ASSOCIATES LLC]	4	Current NDC, 4 package rows	20240906_9e7c759e-d2cb-4505-ad9f-38efaaaeefc2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topcare allergy	MOMETASONE FUROATE MONOHYDRATE	Topco Associates LLC	9e7c759e-d2cb-4505-ad9f-38efaaaeefc2	2026-06-11	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712 ndc (product): 76162-134
Allergy	MOMETASONE FUROATE MONOHYDRATE	Rite Aid Corporation	ec864592-bcee-4f45-97e8-34b28fe9e1a4	2026-06-03	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
allergy	MOMETASONE FUROATE MONOHYDRATE	HyVee Inc	9f83880b-0062-433a-bc4a-00886b975dd3	2026-03-29	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
allergy nasal	MOMETASONE FUROATE MONOHYDRATE	Walgreen Company	9f28b399-0035-4753-8d1b-ddea212f86e8	2026-03-06	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
basic care allergy	MOMETASONE FUROATE MONOHYDRATE	Amazon.com Services LLC	651bd156-bded-4bef-a951-dd35a6d5b97e	2026-02-03	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
ALLERGY RELIEF	MOMETASONE FUROATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	97681a68-c26a-4ec9-ac67-4480878fa43d	2026-01-05	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
Nasonex	MOMETASONE FUROATE	L. Perrigo Company	13696a8b-366a-4a5e-adea-d5b7bff9e46f	2025-08-19	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
Leader Allergy Nasal	MOMETASONE FUROATE	Cardinal Health 110, LLC. dba Leader	26f929e8-0759-4584-a0bf-f7709baa6bee	2025-08-11	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
Rugby mometasone furoate nasal	MOMETASONE FUROATE	Rugby Laboratories	b4c43535-ad22-44c2-b04f-df4348a6c485	2025-08-06	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
allergy	MOMETASONE FUROATE MONOHYDRATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	ca93cfef-56ac-49f9-9dac-36d19189f8a5	2025-03-11	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712
Childrens Nasonex	MOMETASONE FUROATE	L. Perrigo Company	e15d055e-9a25-46b4-8724-3609cf2dc062	2024-08-28	Warnings	Exact identifier application applno (NDA): 215712 application number: NDA215712

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MTW0WEG809	MOMETASONE FUROATE MONOHYDRATE	141646-00-6	MOMETASONE FUROATE MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1797865	mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal Spray	PSN	9e7c759e-d2cb-4505-ad9f-38efaaaeefc2	4
1797865	mometasone furoate 0.05 MG/ACTUAT Metered Dose Nasal Spray	SCD	9e7c759e-d2cb-4505-ad9f-38efaaaeefc2	4
1797865	mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal Spray	SY	9e7c759e-d2cb-4505-ad9f-38efaaaeefc2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76162-134-02	76162013402	1 BOTTLE, SPRAY in 1 CARTON (76162-134-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY	2023-03-28		No	No	Current
76162-134-11	76162013411	1 BOTTLE, SPRAY in 1 CARTON (76162-134-11) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY	2024-03-14	2026-12-01	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Allergy Spray Drug Facts	Topco Associates LLC	2026-06-11	HUMAN OTC DRUG LABEL	5