Indications and uses
to prevent and relieve nasal symptoms of hay fever and other nasal allergies: runny/itchy nose sneezing allergic stuffy nose
Cromolyn Sodium Nasal Solution USP NASAL SPRAY
- Manufacturer
- CVS Pharmacy | Bausch & Lomb Incorporated | Aventis Pharma Manufacturing Pte LTD.
- Effective date
- 2011-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:30:25
Label at a glance#
ProductCromolyn Sodium
Active ingredientCROMOLYN SODIUM
Label structure10 sections
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...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (per spray)
Cromolyn sodium 5.2 mg
Purpose
Nasal allergy symptom controller
Uses
to prevent and relieve nasal symptoms of hay fever and other nasal allergies:
- runny/itchy nose
- sneezing
- allergic stuffy nose
Warnings
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 right away.
Directions
- 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
- store between 20°– 25°C (68°– 77°F)
- protect from light
- keep carton and package insert. They contain important instructions.
Inactive ingredients
benzalkonium chloride, edetate disodium, purified water
Questions?
call toll free 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.
CVS Quality MONEY BACK GURANTEE
Distributed by:
CVS Pharmacy Inc.,
Woonsocket, RI 02895
©2005 CVS/pharmacy
*This product is not manufactured or distributed by Pharmacia & Upjohn Company, owner of the registered trademark NasalCrom®.
Package/Label Principal Display Panel
CVS pharmacy®
Compare to the active ingredient in Nasalcrom®
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
CVS PHARAMACIST RECOMMENDED
200 Metered Sprays
Each spray delivers
5.2 mg cromolyn sodium
0.88 FL OZ (26 mL)
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CROMOLYN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d745b171-bd61-e8c6-cc94-d4add278788b | Product name | 3 | 20230113 |
| a7fea5a7-679e-334b-faff-75e43fb3beb5 | Product name | 2 | 20171208 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59779-075-13 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dc30-f424-e053-dadaa90a57ce | Cromolyn Sodium Nasal Solution USP NASAL SPRAY |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-075-13 | Cromolyn Sodium | 1 in 1 CARTON | SPRAY, METERED | 1 | 1 | |
| 59779-075-13 | Cromolyn Sodium | 26 mL in 1 BOTTLE | SPRAY, METERED | 26 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59779-075-13 | ML - Milliliter | 59779-075 | befedd66-8560-49b8-b28a-dec4e4279085 | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CROMOLYN SODIUM | ACTIVE INGREDIENT | Q2WXR1I0PK | 1 | |
| CROMOLYN | ACTIVE MOIETY | Y0TK0FS77W | 1 |
Products#
Every source-derived product name is available through these pages.
- Cromolyn Sodium
- CROMOLYN
- BENZALKONIUM CHLORIDE
- EDETATE DISODIUM
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59779-075 | 59779-075-13 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROMOLYN SODIUM | Q2WXR1I0PK | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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.
| 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 | A075702-001 | CROMOLYN SODIUM | 5.2MG/SPRAY | SPRAY, METERED / NASAL | RS | 2001-07-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075702-001 | CROMOLYN SODIUM | 5.2MG/SPRAY | SPRAY, METERED / NASAL | RS | 2001-07-03 | caaa826d4ba7… | |
| 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… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 74a45491-238b-48bf-8b14-569e1df61fef | 74a45491-238b-48bf-8b14-569e1df61fef | 2011-12-19 | Warnings | 74a45491-238b-48bf-8b14-569e1df61fef 74a45491-238b-48bf-8b14-569e1df61fef |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.