Cromolyn Sodium

Product NDC: 59779-075
11-digit product format: 597790075
Labeler code: 59779
Product ID: 59779-075_74a45491-238b-48bf-8b14-569e1df61fef
Type: HUMAN OTC DRUG
Nonproprietary name: Cromolyn Sodium
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: CVS Pharmacy
Application: ANDA075702
Marketing category: ANDA
Marketing start: 2001-07-03
Marketing end: 0000-00-00
Substance: CROMOLYN SODIUM
Active strength: 5 mg/mL
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	59779-075		I	Inactivated by FDA		2026-08-11
excluded package	package	59779-075	59779-075-13	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59779-075-13	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59779-075-13	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59779-075-13	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59779-075-13	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59779-075-13	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59779-075-13	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59779-075-13	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59779-075-13	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59779-075-13	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59779-075-13	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59779-075-13	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59779-075-13	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59779-075-13	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59779-075-13	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59779-075-13	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59779-075-13	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59779-075-13	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59779-075-13	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	59779-075-13	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	59779-075-13	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	59779-075-13	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	59779-075-13	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075702-001	CROMOLYN SODIUM	5.2MG/SPRAY	SPRAY, METERED / NASAL	RS	2001-07-03	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59779-075-13	2020-01-31	C162847	48780-1	9d75b9d0-dc30-f424-e053-dadaa90a57ce	Cromolyn Sodium Nasal Solution USP NASAL SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59779-075-13	Cromolyn Sodium	1 in 1 CARTON	SPRAY, METERED	1		1
59779-075-13	Cromolyn Sodium	26 mL in 1 BOTTLE	SPRAY, METERED	26		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-075-13	ML - Milliliter	59779-075	befedd66-8560-49b8-b28a-dec4e4279085	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CROMOLYN SODIUM	ACTIVE INGREDIENT	Q2WXR1I0PK	CROMOLYN SODIUM SPRAY, METERED [CVS PHARMACY]	1
CROMOLYN	ACTIVE MOIETY	Y0TK0FS77W	CROMOLYN SODIUM SPRAY, METERED [CVS PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-075	CROMOLYN SODIUM SPRAY, METERED [CVS PHARMACY]	1	Legacy NDC, 2 package rows	20111222_74a45491-238b-48bf-8b14-569e1df61fef.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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1797851	cromolyn sodium 5.2 MG/ACTUAT Metered Dose Nasal Spray	PSN	74a45491-238b-48bf-8b14-569e1df61fef	1
1797851	cromolyn sodium 5.2 MG/ACTUAT Metered Dose Nasal Spray	SCD	74a45491-238b-48bf-8b14-569e1df61fef	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
59779-075-13	59779007513	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cromolyn Sodium Nasal Solution USP NASAL SPRAY	CVS Pharmacy \| Bausch & Lomb Incorporated \| Aventis Pharma Manufacturing Pte LTD.	2011-12-19	HUMAN OTC DRUG LABEL	1