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 35 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E Bec0b5f4b-b58c-445f-acf1-c7ce301bba642026-04-30WarningsExact identifier
application number: M012
Mucus Relief DM Max Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINHarris Teeter, LLC098428ae-e87d-4c29-8f02-1590530da58e2026-04-29WarningsExact identifier
application number: M012
Panadol Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC341761b9-f0be-f816-e063-6394a90a5e632026-04-29WarningsExact identifier
application number: M012
Panadol Cold and Flu NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3417993d-8e3c-23d6-e063-6394a90a7d502026-04-29WarningsExact identifier
application number: M012
Halls Sugar Free Mountain MentholMENTHOLMondelez Global LLC509f233e-ff01-8927-e063-6394a90a99292026-04-29WarningsExact identifier
application number: M012
Broncomiel AdultsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509c61d3-ae16-be5c-e063-6294a90a68da2026-04-29WarningsExact identifier
application number: M012
Mucus Relief DM Max Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINTOP CARE (Topco Associates LLC)aa1eb90c-e565-455f-8978-6f2f9e00a8142026-04-29WarningsExact identifier
application number: M012
Tussin Cough and Chest Congestion DM adultDEXTROMETHORPHAN HBR, GUAIFENESINHarris Teeter, LLCe1280355-da81-489f-9bd2-ffea9a68010c2026-04-29WarningsExact identifier
application number: M012
Mucus Relief ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC7b095ec5-9951-4491-9b68-7ac0a7f100532026-04-29WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOP CARE (Topco Associates LLC)98dd0ba6-0109-46b2-92df-11a0309842402026-04-28WarningsExact identifier
application number: M012
Pain, Headache and CongestionACETAMINOPHEN, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED41a77cbb-6a4d-46a4-ab27-c7affa2cc6822026-04-28WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.dd7da15a-4e0b-405f-e053-2995a90a06d22026-04-28WarningsExact identifier
application number: M012
CAREONE CHILDRENS COLD COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDERetail Business Services, LLC382f7d51-ceb8-4bdf-9bd5-440b50c65cd32026-04-28WarningsExact identifier
application number: M012
Cold and Flu Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.1a520b4f-6a4b-4e37-94c5-9387f2e4c34a2026-04-27WarningsExact identifier
application number: M012
Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKroger49a7cd2a-8c0e-2196-e063-6294a90a134a2026-04-27WarningsExact identifier
application number: M012
Guaifenesin,Dextromethorphan HbrGUAIFENESIN,DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd3e5d978f-cc70-60a5-e063-6394a90a67d32026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd36ced59c-12dc-441f-e063-6294a90a32392026-04-27WarningsExact identifier
application number: M012
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLSoftgel Healthcare Private Limited30ab39f3-27cc-5728-e063-6394a90a9cbe2026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited353f71f7-81e0-08c2-e063-6294a90acb492026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr ,GuaifenesinACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESINSoftgel Healthcare Pvt Ltd353ef34f-760d-ae92-e063-6294a90a5b4a2026-04-27WarningsExact 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