Cromolyn Sodium

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Cromolyn Sodium
Generic name
CROMOLYN SODIUM
Manufacturer
Bausch & Lomb Incorporated
Product type
HUMAN OTC DRUG
SPL set ID
379f4b59-6866-4b5c-9b1b-d8a35b741461
SPL ID
d66445c2-3e1d-458a-9c62-d4fc2ef4ec8f
Version
8
Effective date
2021-06-01
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:24:03
Harmonized routes table
Harmonized routes
NASAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Do not use • if you are allergic to any of the ingredients Ask a doctor before use if you have • fever • discolored nasal discharge • sinus pain • wheezing When using this product • it may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks. • brief stinging or sneezing may occur right after use • do not use it to treat sinus infection, asthma, or cold symptoms • do not share this bottle with anyone else as this may spread germs Stop use and ask a doctor if • shortness of breath, wheezing, or chest tightness occurs • hives or swelling of the mouth or throat occurs • your symptoms worsen • you have new symptoms • your symptoms do not begin to improve within two weeks • you need to use for more than 12 weeks If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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