nasal

Product NDC
42507-388
11-digit product format
425070388
Labeler code
42507
Product ID
42507-388_ac3c1c7a-c771-41c8-81bc-1d71bfe48250
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
HyVee Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-05-13
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.05 g/100mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42507-388-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42507-388-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42507-388-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42507-388-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42507-388-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42507-388-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42507-388-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42507-388-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42507-388-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42507-388-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42507-388-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42507-388-10557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
nasal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K89MJ0S5VYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8a48a00-3533-4c4d-94e1-8a6c6b35a792Available on FDA.report

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYNASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYNASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74NASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWNASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2
WATERINACTIVE INGREDIENT059QF0KO0RNASAL (OXYMETAZOLINE HCL) SPRAY [HYVEE INC]2

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 74 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cherry cough dropsMENTHOLMeijer5bc2ec81-a3cb-3a59-e053-2a91aa0ac14e2025-12-18WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLMeijer5bc3b9b8-e61e-1041-e053-2a91aa0a3d832025-12-18WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLMeijer5bd35bce-cd85-5314-e053-2991aa0abce62025-12-18WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLMeijer5bd42654-56e5-997e-e053-2a91aa0afd342025-12-18WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLMeijer5bd61cd4-a5ca-9d66-e053-2a91aa0a93a32025-12-18WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLMeijer5bd7c24d-6a61-5d2d-e053-2a91aa0a08ed2025-12-18WarningsExact identifier
application number: M012
SF Honey Lemon Cough DropsMENTHOLMeijer Distribution70e3de9a-1804-ef15-e053-2a95a90a33402025-12-18WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Vanilla HoneyMENTHOLChain Drug Marketing Association, Inc.3d6a4bcc-1044-40f5-928a-378ececcb6872025-12-18WarningsExact identifier
application number: M012
Meijer Strawberry Cough DropsMENTHOLMeijer164de637-e644-711c-e063-6294a90a1c5f2025-12-18WarningsExact identifier
application number: M012
Meijer Severe Menthol Throat DropsMENTHOLMeijer16603ca4-1ce5-2e7e-e063-6394a90ad6f12025-12-18WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLA-S Medication Solutions60587987-c303-4617-ba96-c518ab2a06502025-12-18WarningsExact identifier
application number: M012
NiafluDEXTROMETHORPHAN HBR, GUAIFENESINPharmadel LLC399898f0-e40a-4f5d-e063-6294a90a667d2025-12-17WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLThe Kroget Co.4313a6ce-454d-4c4b-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Menthol cough dropMENTHOLThe Kroger Co.42b257e9-f45e-32c9-e054-00144ff8d46c2025-12-17WarningsExact identifier
application number: M012
Honey Lemon cough dropMENTHOLThe Kroger Co.4318f25a-05d9-2208-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Honey Lemon cough dropMENTHOLThe Kroger Co.4317f952-a228-0281-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLThe Kroger Co.4316df6e-3ae6-4ab5-e054-00144ff88e882025-12-17WarningsExact identifier
application number: M012
SF Honey Lemon Cough DropsMENTHOLThe Kroger Co.43281bd1-f8a7-02a4-e054-00144ff8d46c2025-12-17WarningsExact identifier
application number: M012
Kroger Cherry Cough DropsMENTHOLKrogera2e1d1f5-9b19-1704-e053-2a95a90abb512025-12-17WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CF AdultDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINEMajor Pharmaceuticalsa9958b7d-7060-422b-a098-c1925c2460812025-12-17WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42507-388-10425070388101 BOTTLE, SPRAY in 1 CARTON (42507-388-10) / 30 mL in 1 BOTTLE, SPRAY (42507-388-30) 2002-05-13NoNoCurrent