NasalCrom

Product NDC: 52183-199
Requested package NDC: 52183-199-14
11-digit product format: 521830199
Labeler code: 52183
Product ID: 52183-199_0a2a4a89-e8ee-46a0-8187-3e1192c39985
Type: HUMAN OTC DRUG
Nonproprietary name: cromolyn sodium
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Prestige Brands Holdings, Inc.
Application: ANDA075702
Marketing category: ANDA
Marketing start: 2009-10-29
Substance: CROMOLYN SODIUM
Active strength: 5.2 mg/1
Pharmacologic classes: Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52183-199	52183-199-14	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075702-001	CROMOLYN SODIUM	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL		RS	2001-07-03

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CROMOLYN SODIUM	5.2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q2WXR1I0PK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1797851	Internal RxNorm lookup
1797853	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
b34d36ca-4df4-458c-af0f-c0d0c9a025d9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d745b171-bd61-e8c6-cc94-d4add278788b	Product name	3	20230113
a7fea5a7-679e-334b-faff-75e43fb3beb5	Product name	2	20171208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52183-199-13	NasalCrom	1 in 1 CARTON	SPRAY, METERED	1	13
52183-199-13	NasalCrom	200 in 1 BOTTLE, PUMP	SPRAY, METERED	200	13
52183-199-14	NasalCrom	1 in 1 CARTON	SPRAY, METERED	1	13
52183-199-14	NasalCrom	100 in 1 BOTTLE, PUMP	SPRAY, METERED	100	13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CROMOLYN SODIUM	ACTIVE INGREDIENT	Q2WXR1I0PK	NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.]	3
CROMOLYN	ACTIVE MOIETY	Y0TK0FS77W	NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52183-199	NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.]	11	Current NDC, Legacy NDC, 4 package rows	20231206_b34d36ca-4df4-458c-af0f-c0d0c9a025d9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NasalCrom	CROMOLYN SODIUM	Prestige Brands Holdings, Inc.	b34d36ca-4df4-458c-af0f-c0d0c9a025d9	2026-06-03	Warnings	Exact identifier application applno (ANDA): 075702 application number: ANDA075702 ndc (package): 52183-199-14 ndc (product): 52183-199 ndc11 (package): 52183019914
Cromolyn Sodium	CROMOLYN SODIUM	Bausch & Lomb Incorporated	379f4b59-6866-4b5c-9b1b-d8a35b741461	2021-06-01	Warnings	Exact identifier application applno (ANDA): 075702 application number: ANDA075702

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q2WXR1I0PK	CROMOLYN SODIUM	15826-37-6	CROMOLYN SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52183-199-14	52183019914	1 BOTTLE, PUMP in 1 CARTON (52183-199-14) > 100 SPRAY, METERED in 1 BOTTLE, PUMP	2009-10-29	0000-00-00	No	No	Current