FDA.reportPublic FDA data

Family Care Nasal Relief

Product NDC
65923-571
11-digit product format
659230571
Labeler code
65923
Product ID
65923-571_42418306-7444-676c-e063-6294a90a4da7
Type
HUMAN OTC DRUG
Nonproprietary name
OXYMETAZOLINE HYDROCHLORIDE
Dosage form
SPRAY
Route
NASAL
Labeler
United Exchange Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-31
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
5 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
Family Care Nasal Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE5 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6d0f8e9e-0503-522b-e053-2a91aa0aca35Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-03-31Family Care Nasal Spray Severe Congestion 0.5 oz NBE Afrin Severe Congestion 571 ZDP
2022-03-31Family Care Nasal Spray Severe Congestion 0.5 oz 571 ZDP
2022-01-28Family Care Nasal Spray Severe Congestion 0.5 oz NBE Afrin Severe Congestion 571 ZDP
2022-01-28Family Care Nasal Spray Severe Congestion 0.5 oz 571 ZDP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-571-15Family Care Nasal Relief1 in 1 CARTONSPRAY18
65923-571-15Family Care Nasal Relief15 mL in 1 BOTTLE, SPRAYSPRAY158

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-571FAMILY CARE NASAL RELIEF (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [UNITED EXCHANGE CORP]7Current NDC, Legacy NDC, 2 package rows20241222_6d0f8e9e-0503-522b-e053-2a91aa0aca35.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 101 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories, Inc3f79137f-f0b0-d22c-e063-6394a90a72452025-09-23WarningsExact identifier
application number: M012
GoodSense Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLGOOD SENSE240bb6af-9d38-49fe-9011-3016246b09862025-09-23WarningsExact identifier
application number: M012
Xpect Honey Lemon Cough DropsHONEY LEMON COUGH DROPSCintas Corporation79e0b7c1-4acc-41d2-89cd-d075a8bac0c92025-09-23WarningsExact identifier
application number: M012
Topcare NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCb2b3c450-e988-41d1-9e53-cc8e30d75cb42025-09-23WarningsExact identifier
application number: M012
Xpect Cherry Cough DropsCHERRY COUGH DROPSCintas Corporationd1fd2f23-5435-405d-a7fd-644691f79e802025-09-23WarningsExact identifier
application number: M012
Topcare DayTime NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLC560fb22b-391f-4d7b-a6fd-38d577d404b02025-09-23WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f67ac3d-1503-3418-e063-6394a90a938f2025-09-22WarningsExact identifier
application number: M012
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories Inc.3f68e68a-cf32-9df8-e063-6394a90a30122025-09-22WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKramer Novisf0bec5f5-4d76-471e-9024-557eba848b932025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.9f050fb0-6100-4b14-b82f-1d5fcbf165402025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.c6392ace-c7d1-4450-8b71-4dccc60b4f022025-09-22WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f12ee8f-d1c6-d73a-e063-6394a90a91992025-09-18WarningsExact identifier
application number: M012
CVS Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy3d71d306-893a-e73a-e063-6394a90a0a3b2025-09-18WarningsExact identifier
application number: M012
Giltuss DGILTUSS DDextrum Laboratories Inc.3f17eefb-b625-b0f2-e063-6294a90afd4d2025-09-18WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMajor Pharmaceuticals6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b2025-09-17WarningsExact identifier
application number: M012
Childrens Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories Inc3effaf4b-28c3-6131-e063-6294a90a17ff2025-09-17WarningsExact identifier
application number: M012
AXIV DayTime - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC1872e1ff-2e08-c404-e063-6294a90afa142025-09-17WarningsExact identifier
application number: M012
AXIV AllergyDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1323a67c-b9c5-038c-e063-6394a90a5e6b2025-09-17WarningsExact identifier
application number: M012
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f025ef6-79e7-e833-e063-6294a90ab5012025-09-17WarningsExact identifier
application number: M012
AXIV Night Time - LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEVIVUNT PHARMA LLC186f8519-655d-bd21-e063-6294a90a16a82025-09-17WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65923-571-15659230571151 BOTTLE, SPRAY in 1 CARTON (65923-571-15) / 15 mL in 1 BOTTLE, SPRAY2018-05-250000-00-00NoNoCurrent