Cromolyn Sodium

Product NDC: 61314-237
Requested package NDC: 61314-237-10
11-digit product format: 613140237
Labeler code: 61314
Product ID: 61314-237_bfef6d6b-b5e5-4f8c-89c5-718e2c65cc6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cromolyn Sodium
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: ANDA075282
Marketing category: ANDA
Marketing start: 1999-06-29
Substance: CROMOLYN SODIUM
Active strength: 40 mg/mL
Pharmacologic classes: Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A075282-001	CROMOLYN SODIUM	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC		RS	1999-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075282-001	CROMOLYN SODIUM	4%	SOLUTION/DROPS / OPHTHALMIC	AT		1999-06-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075282-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075282-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075282-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075282-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075282-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075282-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075282-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075282-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075282-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075282-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075282-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075282-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075282-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A075282-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075282-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075282-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075282-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075282-001	AT	1	`cb3db0bc1861…`

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: Cromolyn Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CROMOLYN SODIUM	40 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
831109	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
b32851c3-cd97-4be4-a09c-1deab1d6966b	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	Strength	SPL version
61314-237-10	Cromolyn Sodium	10 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-237-10	ML - Milliliter	61314-237	dd4db819-272b-42a8-8358-82b81bef6f1c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CROMOLYN SODIUM	ACTIVE INGREDIENT	Q2WXR1I0PK	CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC]	3
CROMOLYN	ACTIVE MOIETY	Y0TK0FS77W	CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-237	CROMOLYN SODIUM SOLUTION/ DROPS [SANDOZ INC]	6	Current NDC, Legacy NDC, 1 package rows	20220218_b32851c3-cd97-4be4-a09c-1deab1d6966b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cromolyn Sodium	CROMOLYN SODIUM	Preferred Pharmaceuticals Inc.	18892411-465f-4d8d-9550-7dafa6c6a0a3	2026-04-01	Adverse reactions	Exact identifier application applno (ANDA): 075282 application number: ANDA075282
Cromolyn Sodium	CROMOLYN SODIUM	Sandoz Inc	b32851c3-cd97-4be4-a09c-1deab1d6966b	2025-02-20	Adverse reactions	Exact identifier application applno (ANDA): 075282 application number: ANDA075282 ndc (package): 61314-237-10 ndc (product): 61314-237 ndc11 (package): 61314023710
Cromolyn Sodium	CROMOLYN SODIUM	A-S Medication Solutions	0d30fb0a-e343-426d-8203-5816bd4cec2f	2024-11-07	Adverse reactions	Exact identifier application applno (ANDA): 075282 application number: ANDA075282
Cromolyn Sodium	CROMOLYN SODIUM	Proficient Rx LP	34ef00e8-0c01-4225-9a40-822ab245752a	2019-10-01	Adverse reactions	Exact identifier application applno (ANDA): 075282 application number: ANDA075282

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
831109	cromolyn sodium 4 % Ophthalmic Solution	PSN	0d30fb0a-e343-426d-8203-5816bd4cec2f	14
831109	cromolyn sodium 40 MG/ML Ophthalmic Solution	SCD	0d30fb0a-e343-426d-8203-5816bd4cec2f	14
831109	cromolyn sodium 4 % Ophthalmic Solution	SY	0d30fb0a-e343-426d-8203-5816bd4cec2f	14
831109	cromolyn sodium 4 % Ophthalmic Solution	PSN	b32851c3-cd97-4be4-a09c-1deab1d6966b	6
831109	cromolyn sodium 40 MG/ML Ophthalmic Solution	SCD	b32851c3-cd97-4be4-a09c-1deab1d6966b	6
831109	cromolyn sodium 4 % Ophthalmic Solution	SY	b32851c3-cd97-4be4-a09c-1deab1d6966b	6
831109	cromolyn sodium 4 % Ophthalmic Solution	PSN	18892411-465f-4d8d-9550-7dafa6c6a0a3	5
831109	cromolyn sodium 40 MG/ML Ophthalmic Solution	SCD	18892411-465f-4d8d-9550-7dafa6c6a0a3	5
831109	cromolyn sodium 4 % Ophthalmic Solution	SY	18892411-465f-4d8d-9550-7dafa6c6a0a3	5
831109	cromolyn sodium 4 % Ophthalmic Solution	PSN	f7a6334c-7b98-4730-8ee6-ca37cf87bba3	3
831109	cromolyn sodium 40 MG/ML Ophthalmic Solution	SCD	f7a6334c-7b98-4730-8ee6-ca37cf87bba3	3
831109	cromolyn sodium 4 % Ophthalmic Solution	SY	f7a6334c-7b98-4730-8ee6-ca37cf87bba3	3
831109	cromolyn sodium 4 % Ophthalmic Solution	PSN	34ef00e8-0c01-4225-9a40-822ab245752a	2
831109	cromolyn sodium 40 MG/ML Ophthalmic Solution	SCD	34ef00e8-0c01-4225-9a40-822ab245752a	2
831109	cromolyn sodium 4 % Ophthalmic Solution	SY	34ef00e8-0c01-4225-9a40-822ab245752a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-237-10	61314023710	1 BOTTLE, PLASTIC in 1 CARTON (61314-237-10) / 10 mL in 1 BOTTLE, PLASTIC	1999-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cromolyn Sodium Ophthalmic Solution USP, 4% Sterile	Preferred Pharmaceuticals Inc.	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	5
Cromolyn Sodium Ophthalmic Solution USP, 4% Rx Only STERILE	Sandoz Inc	2025-02-20	HUMAN PRESCRIPTION DRUG LABEL	7
Cromolyn Sodium Ophthalmic Solution USP, 4% Sterile	A-S Medication Solutions	2024-11-07	HUMAN PRESCRIPTION DRUG LABEL	14
Cromolyn Sodium Ophthalmic Solution USP, 4% Sterile	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	3
Cromolyn Sodium Ophthalmic Solution USP, 4% Sterile	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	2