nasal

Product NDC
37808-021
Requested package NDC
37808-021-10
11-digit product format
378080021
Labeler code
37808
Product ID
37808-021_7ab5bfe0-8dda-4c8c-9e8d-fc4391ea9957
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
H E B
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-02-03
Marketing end
0000-00-00
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37808-02137808-021-10DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TKNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2
WATERINACTIVE INGREDIENT059QF0KO0RNASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-021NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [H E B]4Legacy NDC20241019_b1fe7396-3b3e-404f-9ce3-00e8ca1d2ffa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-021-10378080021101 BOTTLE, SPRAY in 1 CARTON (37808-021-10) > 30 mL in 1 BOTTLE, SPRAY2015-02-030000-00-00NoNoCurrent