Home NDC 57782-397 Cromolyn Sodium
Product NDC 57782-397
11-digit product format 577820397
Labeler code 57782
Product ID 57782-397_d66445c2-3e1d-458a-9c62-d4fc2ef4ec8f
Type HUMAN OTC DRUG
Nonproprietary name Cromolyn Sodium
Dosage form SPRAY, METERED
Route NASAL
Labeler Bausch & Lomb Incorporated
Application ANDA075702
Marketing category ANDA
Marketing start 2001-07-03
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 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 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 Product TE source text 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…
Additional Listing Data#
Finished product Yes
Brand name base Cromolyn Sodium
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797851 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57782-397-26 Cromolyn Sodium 200 in 1 BOTTLE SPRAY, METERED 200 8 57782-397-26 Cromolyn Sodium 1 in 1 CARTON SPRAY, METERED 1 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57782-397 CROMOLYN SODIUM SPRAY, METERED [BAUSCH & LOMB INCORPORATED] 8 Current NDC, Legacy NDC, 2 package rows 20230201_379f4b59-6866-4b5c-9b1b-d8a35b741461.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57782-397-26 57782039726 1 BOTTLE in 1 CARTON (57782-397-26) / 200 SPRAY, METERED in 1 BOTTLE 1 bottle 2001-07-03 0000-00-00 No No Current