FDA.reportPublic FDA data

Congestion Relief

Product NDC
66715-6860
11-digit product format
667156860
Labeler code
66715
Product ID
66715-6860_2a92670f-80b1-abdb-e063-6294a90a6342
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Lil' Drug Store Products, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-01
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

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
Congestion Relief
Brand name suffix
Lil Drug Store Products
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
8fca348c-ecb6-4a91-89dd-8bd4c05ac745Available 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
66715-6860-4Congestion ReliefLil Drug Store Products30 mL in 1 BOTTLE, SPRAYSPRAY307
66715-6860-4Congestion ReliefLil Drug Store Products1 in 1 CARTONSPRAY17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxymetazoline HydrochlorideACTIVE INGREDIENTK89MJ0S5VYCONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]1
OxymetazolineACTIVE MOIETY8VLN5B44ZYCONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7CONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KCONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ACONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]1
PovidonesINACTIVE INGREDIENTFZ989GH94ECONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]1
Sodium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENT22ADO53M6FCONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]1
Sodium Phosphate, Monobasic, AnhydrousINACTIVE INGREDIENTKH7I04HPUUCONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]1
WaterINACTIVE INGREDIENT059QF0KO0RCONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6860CONGESTION RELIEF LIL DRUG STORE PRODUCTS (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [LIL' DRUG STORE PRODUCTS, INC]7Current NDC, Legacy NDC, 2 package rows20250101_8fca348c-ecb6-4a91-89dd-8bd4c05ac745.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 78 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp5015a380-a229-4eff-8e31-528065c6ed642025-12-09WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHarris Teetercaf59320-5b48-4533-bda9-7b03a2fde0b52025-12-09WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC30d41dc3-e2ef-4cad-b63c-d634bc749aa12025-12-09WarningsExact identifier
application number: M012
Walgreens Childrens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company327a7226-84b9-26d7-e063-6394a90a99b92025-12-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR AND GUAIFENESINMeijer Distribution Inc8ed5b802-a26e-45b4-a696-bc64dbac47332025-12-09WarningsExact identifier
application number: M012
dg health cold plus flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCff4a2f0a-d638-4ed2-8e05-2a52afbc49092025-12-09WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)24894484-b834-4b2f-b365-c95b5e30d8bf2025-12-09WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEFamily Dollar (FAMILY WELLNESS)2c431220-c61b-4ad5-9ad2-58ccaee2d1c32025-12-09WarningsExact identifier
application number: M012
Sinus PE Congestion Daytime NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLMeijer Distribution, Inc.9da77306-5098-4c79-845c-97ead849c84a2025-12-08WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)fdd0dadc-5313-4f6e-aef5-ca853efe5c4d2025-12-08WarningsExact identifier
application number: M012
MucolyteGUAIFENESINRising Pharma Holdings, Inc.e4091aaf-44e3-4701-9986-aff248a2f1b82025-12-08WarningsExact identifier
application number: M012
Mucolyte DMGUAIFENESIN, DEXTROMETHORPHAN HBRRising Pharma Holdings, Inc.c913d27d-bc00-4ace-9a5f-c55522e1cd1d2025-12-08WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLAmerican Sales47f504d5-3ec5-5227-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Sugar Free Menthol Cough DropsMENTHOLAmerican Sales4893ac0a-7769-5657-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
Cherry cough dropMENTHOLAmerican Sales45e891ea-2f2a-31b7-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINEAmerican Sales49248a40-1ca3-6dd1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLAmerican Sales4896cbd1-57dd-1fc6-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
cherry throat relief lozengesBENZOCAINECintas Corporation49b25e9e-1d47-4a10-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
cherry sore throat lozengeBENZOCAINECVS Pharmacy3c54974d-9d15-2fa1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
honey lemon sore throat lozengesBENZOCAINECVS Pharmacy3c55009c-4b3e-135e-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN8fca348c-ecb6-4a91-89dd-8bd4c05ac7457
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD8fca348c-ecb6-4a91-89dd-8bd4c05ac7457
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY8fca348c-ecb6-4a91-89dd-8bd4c05ac7457

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66715-6860-4667156860041 BOTTLE, SPRAY in 1 CARTON (66715-6860-4) / 30 mL in 1 BOTTLE, SPRAY2019-12-150000-00-00NoNoCurrent