Cromolyn Sodium Inhalation Solution

Manufacturer: Holopack Verpackungstechnik GmbH
Effective date: 2021-11-15
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-01 22:25:43

Label at a glance#

ProductCromolyn Sodium Inhalation Solution

Active ingredientCROMOLYN SODIUM

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cromolyn Sodium Inhalation Solution, USP

999

20 mg/2 mL Rx only

NDC Code Fera: 48102-033-60

NDC Code Holopack: 60940-032-01

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature.

Distrubuted by:

Fera Pharmaceuticals, LLC

Locust Valley, NY 11560

Mfd. By:

Holopack Verpackungstechnik GmbH

Bahnhofstr., 74429 Sulzbach-Laufen

Germany

Holopack Material No.: 011-01512

EXP 08/2023 LOT TEST03 QTY20

(17)230830(10)TEST03(30)20

(01)10348102033609(21)12345678901234

Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Cromolyn Sodium Inhalation Solution
Cromolyn Sodium
WATER
CROMOLYN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60940-032	60940-032-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
CROMOLYN SODIUM	Q2WXR1I0PK	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A075437-001	CROMOLYN SODIUM	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN		2000-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075437-001	AN

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION		2000-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075437-001	CROMOLYN SODIUM	10MG/ML	SOLUTION / INHALATION	AN	2000-04-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075437-001	AN	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075437-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075437-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075437-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075437-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075437-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075437-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075437-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075437-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075437-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075437-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075437-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075437-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075437-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075437-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075437-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075437-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075437-001	AN	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075437-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075437-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075437-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075437-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075437-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075437-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075437-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075437-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075437-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075437-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075437-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075437-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075437-001	AN	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075437-001	AN	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d0d730f8-3407-9f18-e053-2995a90a34c7			d0d730f8-3406-9f18-e053-2995a90a34c7	2021-11-15		Exact identifier spl id: d0d730f8-3407-9f18-e053-2995a90a34c7 spl set id: d0d730f8-3406-9f18-e053-2995a90a34c7

Reported adverse events (FAERS/openFDA)#

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