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#

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 149 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.ec6aef90-ece1-4fe6-e053-2995a90a93102024-10-16WarningsExact identifier
application number: M012
Tukol MAX ACTION Cold, Sore Throat and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Incc8eebe64-00bf-436d-a9fc-1623401bebfa2024-10-16WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart4f42c8d2-0538-4bcd-aac0-e26103a304992024-10-16WarningsExact identifier
application number: M012
Tukol MAX ACTION Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Inc9ac3e24a-d18a-48fc-8005-55393085d57b2024-10-16WarningsExact identifier
application number: M012
Nighttime CoughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED45471fdd-c4cd-46ad-a932-aa37327e8a412024-10-16WarningsExact identifier
application number: M012
DG Health Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc8cb15a8d-c836-4167-bc6b-dd20a34076e82024-10-16WarningsExact identifier
application number: M012
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLCf4497e56-c69d-4ae9-bd81-80bf2ee1b17f2024-10-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFOODHOLD U.S.A., LLC8256c1fb-683d-56ab-e053-2a91aa0ac1972024-10-15WarningsExact identifier
application number: M012
SINUS SEVREACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f9586e3-a8b4-4060-e053-2995a90aa0682024-10-15WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f95715f-63dc-6086-e053-2a95a90adb0c2024-10-15WarningsExact identifier
application number: M012
Allergy MultiSymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.a61636e9-8fe2-8419-e053-2a95a90a011c2024-10-15WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f95b2e8-dea4-ef59-e053-2a95a90a0bcb2024-10-15WarningsExact identifier
application number: M012
Cold Multi-Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmerican Sales Companyd2dcbc7c-e66c-4922-83df-c706a37bf3342024-10-15WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC. (9f958d97-8dcf-332d-e053-2995a90a0a652024-10-15WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERetail Business Services , LLC.8bc68a71-62c5-a04f-e053-2995a90a92fd2024-10-15WarningsExact identifier
application number: M012
COLD FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f960566-0158-6637-e053-2995a90a9c4a2024-10-15WarningsExact identifier
application number: M012
HEAD CONGESTION PLUS FLU SEVERE PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.e65cf21d-3d69-a53e-e053-2a95a90a1c832024-10-15WarningsExact identifier
application number: M012
night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH E B49f5f4d3-556c-4ee3-b5cd-5331dd434bb92024-10-15WarningsExact identifier
application number: M012
Mielim y masDEXTROMETHORPHANEfficient Laboratories Inc.711d1dae-3af4-46af-a3a8-cd827356a81a2024-10-14WarningsExact identifier
application number: M012
Tukol Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA27ab3d86-e960-4d83-aad1-d50d2c8e02a92024-10-14WarningsExact 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