NasalCrom

Manufacturer: Prestige Brands Holdings, Inc.
Effective date: 2026-06-03
Label type: HUMAN OTC DRUG LABEL
Version: 14
Source: daily-update
Hydrated at: 2026-06-04 05:10:18

Label at a glance#

ProductNasalCrom

Active ingredientCROMOLYN SODIUM

Label structure10 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...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-925-5374

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NasalCrom

Drug Facts

Active ingredient (per spray)

OTC - ACTIVE INGREDIENT SECTION

Cromolyn sodium 5.2mg

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

For external use only

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 (1-800-222-1222) 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

OTHER SAFETY INFORMATION

store between 20-25°C (68-77°F)
protect from light
keep carton and package insert. They contain important instructions.
see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, edetate disodium, purified water

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-9-ALLERGY (1-877-925-5374)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NASAL SPRAY

NasalCrom ^®

cromolyn sodium nasal solution, USP
NASAL ALLERGY SYMPTOM CONTROLLER

Original Prescription Strength

Safe for ages 2+

200 Metered Sprays / Each spray delivers 5.2 mg cromolyn sodium

0.88 FL OZ (26 mL)

Principal Display Panel NASAL SPRAY NasalCrom ® cromolyn sodium nasal solution, USP NASAL ALLERGY SYMPTOM CONTROLLER Original Prescription Strength Safe for ages 2+ 200 Metered ...

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CROMOLYN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d745b171-bd61-e8c6-cc94-d4add278788b	Product name	3	20230113
a7fea5a7-679e-334b-faff-75e43fb3beb5	Product name	2	20171208

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CROMOLYN SODIUM	ACTIVE INGREDIENT	Q2WXR1I0PK	3
CROMOLYN	ACTIVE MOIETY	Y0TK0FS77W	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NasalCrom
cromolyn sodium
CROMOLYN
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52183-199	52183-199-13, 52183-199-14

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
CROMOLYN SODIUM	Q2WXR1I0PK	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
13	2025-10-30	full-release	2026-06-01 01:28:28

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL	1 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL	4 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL	4 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL	1 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL	4 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL	1 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates

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
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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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.

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
NasalCrom	CROMOLYN SODIUM	Prestige Brands Holdings, Inc.	b34d36ca-4df4-458c-af0f-c0d0c9a025d9	2026-06-03	Warnings	Exact identifier ndc (package): 52183-199-14 ndc (package): 52183-199-13 ndc (product): 52183-199 ndc11 (package): 52183019914 ndc11 (package): 52183019913 spl id: 0a2a4a89-e8ee-46a0-8187-3e1192c39985 spl set id: b34d36ca-4df4-458c-af0f-c0d0c9a025d9

Reported adverse events (FAERS/openFDA)#

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