Cromolyn Sodium Nasal Solution USP NASAL SPRAY

Manufacturer
Cardinal Health | Bausch & Lomb Incorporated | Aventis Pharma Manufacturing Pte LTD.
Effective date
2011-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:50:03

Label at a glance#

ProductCromolyn Sodium
Active ingredientCROMOLYN SODIUM
Label structure11 sections

Indications and uses

to prevent and relieve nasal symptoms of hay fever and other nasal allergies: runny/itchy nose sneezing allergic stuffy nose

Dosage and administration

see package insert on how to use pump parent or care provider must supervise the use of this product by young children adults and children 2 years and older: spray once into each nostril. Repeat 3-4 times a day (every 4-6 hours). If needed, may be used up to 6 times a day. use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust) to prevent nasal allergy symptoms, use before c...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

 

Active ingredient (per spray)

OTC - ACTIVE INGREDIENT SECTION

Cromolyn sodium 5.2 mg

Purpose

OTC - PURPOSE SECTION

Nasal allergy symptom controller

Uses

INDICATIONS & USAGE SECTION

to prevent and relieve nasal symptoms of hay fever and other nasal allergies:

  • runny/itchy nose
  • sneezing
  • allergic stuffy nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to any of the ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • discolored nasal discharge
  • sinus pain
  • wheezing

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • see package insert on how to use pump
  • parent or care provider must supervise the use of this product by young children
  • adults and children 2 years and older:
    • spray once into each nostril. Repeat 3-4 times a day (every 4-6 hours). If needed, may be used up to 6 times a day.
    • use every day while in contact with the cause of your allergies (pollen, molds, pets, and dust)
    • to prevent nasal allergy symptoms, use before contact with the cause of your allergies. For best results, start using up to one week before contact.
    • if desired, you can use this product with other medicines, including other allergy medicines.
  • Children under 2 years: Do not use unless directed by a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • store between 20°– 25°C (68°– 77°F)
  • protect from light
  • keep carton and package insert. They contain important instructions.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, edetate disodium, purified water

Questions?

OTC - QUESTIONS SECTION

Serious side effects associated with the use of this product may be reported to 1-800-323-0000.

Before using any medication read all label directions. Keep carton and packaging insert. They contain important information.

Cromolyn Sodium Nasal Solution is convenient and easy to administer using the metered spray pump. See package insert for spray pump directions.

USE ONLY IF BODY SEAL IMPRINTED WITH "Protective Seal" AND YELLOW IS INTACT.

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017

CIN 3653011

www.myleader.com 1800-200-6313

©Cardinal Health Leader is a trademark of Cardinal Health

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
Carton

NDC 37205-223-61

LEADER®

Compare to Nasalcrom® active ingredient*

Cromolyn Sodium Nasal Solution USP

NASAL SPRAY

Nasal Allergy Symptom Controller

Prevents and Relieves Nasal Allergy Symptoms:
runny/itchy nose
sneezing
allergic stuffy nose

Without Drowsiness

Full Prescription Strength

Safe For Ages 2 Years & Older

SATISFACTION GURANTEED 200 Metered Sprays

Each spray delivers

5.2 mg cromolyn sodium

0.88 FL OZ (26 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-223-612025-04-08C16284748780-19d75b9d0-05aa-f424-e053-dadaa90a57ceCromolyn Sodium Nasal Solution USP NASAL SPRAY
37205-223-612020-01-31C16284748780-19d75b9d0-05aa-f424-e053-dadaa90a57ceCromolyn Sodium Nasal Solution USP NASAL SPRAY

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-223-61ML - Milliliter37205-22302435f4b-26dc-4d6c-a8b4-ad17379e83f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CROMOLYN SODIUMACTIVE INGREDIENTQ2WXR1I0PK1
CROMOLYNACTIVE MOIETYY0TK0FS77W1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-22337205-223-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075702-001CROMOLYN SODIUMCROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03c2088c7a36db…
2026-09-14 22:38:342026-08A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-0384e616aacf4f…
2026-08-18 06:07:402026-07A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-033f01610625f2…
2019-09-15 20:21 UTC2019-09A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075702-001CROMOLYN SODIUM5.2MG/SPRAYSPRAY, METERED / NASALRS2001-07-033a93d1ddd44b…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bd7d6d85-daea-40b6-b7ce-0d7ec1803835fc05700f-0a6b-4693-a3f4-3211606f660d2025-04-07WarningsExact identifier
spl set id: fc05700f-0a6b-4693-a3f4-3211606f660d

Reported adverse events (FAERS/openFDA)#

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