FDA.reportPublic FDA data

dg health nasal

Product NDC
55910-304
11-digit product format
559100304
Labeler code
55910
Product ID
55910-304_8e2f29ba-ede7-4e01-9289-960ac7698465
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Dolgencorp, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-08
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
2026-12-31
Current FDA listing
Yes

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
dg health nasal
Brand name suffix
original
Listing expiration
2026-12-31

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
fb209752-705a-4bb0-9298-8b70357f3911Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-304-10dg health nasaloriginal30 mL in 1 BOTTLE, SPRAYSPRAY3012
55910-304-10dg health nasaloriginal1 in 1 CARTONSPRAY112
55910-304-72dg health nasaloriginal37 mL in 1 BOTTLE, SPRAYSPRAY3712
55910-304-72dg health nasaloriginal1 in 1 CARTONSPRAY112

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYDG HEALTH NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]4
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYDG HEALTH NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDG HEALTH NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDG HEALTH NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EDG HEALTH NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DG HEALTH NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74DG HEALTH NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDG HEALTH NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RDG HEALTH NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-304DG HEALTH NASAL ORIGINAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [DOLGENCORP, LLC]12Current NDC, Legacy NDC, 4 package rows20241105_fb209752-705a-4bb0-9298-8b70357f3911.zip

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 108 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals1b591e27-b00b-41c8-9fe9-c633aba091342025-08-01WarningsExact identifier
application number: M012
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.377248b6-d64d-8dff-e063-6394a90a43f62025-07-31WarningsExact identifier
application number: M012
meijer Daytime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEMeijer, Inc.3771f778-7ac9-7108-e063-6394a90a11052025-07-31WarningsExact identifier
application number: M012
tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca2025-07-31WarningsExact identifier
application number: M012
Equate NasalOXYMETAZOLINE HCLWal-Mart Stores Incc38a2783-aed9-466d-8976-59d03a792c042025-07-30WarningsExact identifier
application number: M012
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3b15d2ea-f784-275d-e063-6394a90a800c2025-07-29WarningsExact identifier
application number: M012
Respiratory ReliefGUAIFENESINSchwabe North America, Incf683041a-4ff9-42a5-9047-a9a3140a87582025-07-29WarningsExact identifier
application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCb87f700e-3414-463c-80d4-c3dbca89a4882025-07-29WarningsExact identifier
application number: M012
Tussin DMTUSSIN DMAllegiant Health7a2f8d48-3123-4c37-b238-bd7cc4242bb72025-07-23WarningsExact identifier
application number: M012
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Inc5fb2438b-8f2d-4af2-9981-42d278d268002025-07-23WarningsExact identifier
application number: M012
DR. SANA COUGH AND CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Incbaca0580-4c30-4b94-89fa-a7cf06d4ff252025-07-22WarningsExact identifier
application number: M012
Defensol DACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCIMenper Distributors, Inc.f466c660-69eb-4581-81ff-1499fa421d8b2025-07-22WarningsExact identifier
application number: M012
Defensol D Blister PackACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCIMenper Distributors, Inc.0dfcc977-6101-4536-e063-6294a90a7a482025-07-22WarningsExact identifier
application number: M012
BroncofinDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMenper Distributors, Inc.fdf67382-1692-485b-92f1-2cbb8be4fb702025-07-22WarningsExact identifier
application number: M012
Defensol Adult SyrupGUAIFENESIN, DEXTROMETHORPHAN HBRMenper Distributors, Inc.62acff69-8c40-4a0e-8d56-be2cc14e3d452025-07-22WarningsExact identifier
application number: M012
Cosedal DropsDEXTROMETHORPHAN HBR, GUAIFENESINMenper Distributors, Inc.1241d249-ea3b-4d2b-87ed-835d6a2d286a2025-07-22WarningsExact identifier
application number: M012
Berro y Cebolla DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMenper Distributors, Inc.20107bd9-6d84-4ab5-a0d9-966f1f11d9192025-07-22WarningsExact identifier
application number: M012
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
application number: M012
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
application number: M012
Bisolvine Aloe-MielDEXTROMETHORPHAN, GUAIFENESINMENPER DISTRIBUTORS INC.34801c79-ce88-492f-808e-b639e86016072025-07-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNfb209752-705a-4bb0-9298-8b70357f391112
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDfb209752-705a-4bb0-9298-8b70357f391112
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYfb209752-705a-4bb0-9298-8b70357f391112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-304-10559100304101 BOTTLE, SPRAY in 1 CARTON (55910-304-10) / 30 mL in 1 BOTTLE, SPRAY2010-01-080000-00-00NoNoCurrent
55910-304-72559100304721 BOTTLE, SPRAY in 1 CARTON (55910-304-72) / 37 mL in 1 BOTTLE, SPRAY2010-01-080000-00-00NoNoCurrent