FDA.reportPublic FDA data

Zicam Extreme Congestion Relief

Product NDC
10237-464
11-digit product format
102370464
Labeler code
10237
Product ID
10237-464_45a8542f-37c2-3200-e063-6394a90ac1fe
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Church & Dwight Co., Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-01
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
.5 mg/mL
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
Zicam Extreme Congestion Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.5 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000990Internal RxNorm lookup
1001084Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ccada339-656c-a461-e053-2a95a90a3479Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10237-464-152023-03-09C16284748780-1f386c64a-1e1c-0266-e053-dadaa90a7c1aZicam ® Extreme Congestion Relief Nasal Spray
10237-464-152023-01-30C16284748780-1f386c64a-1e1c-0266-e053-dadaa90a7c1aZicam ® Extreme Congestion Relief Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-464-15Zicam Extreme Congestion Relief1 in 1 CARTONSPRAY14
10237-464-15Zicam Extreme Congestion Relief15 mL in 1 BOTTLE, PLASTICSPRAY154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-464ZICAM EXTREME CONGESTION RELIEF (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [CHURCH & DWIGHT CO., INC.]3Current NDC, Legacy NDC, 2 package rows20241121_ccada339-656c-a461-e053-2a95a90a3479.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 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange CremeDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC66543190-1d3d-4259-ae73-d366ecbf9e522026-05-12WarningsExact identifier
application number: M012
basic care daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC612719a9-fa2e-4c40-8f35-a399aeaafecc2026-05-12WarningsExact identifier
application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company3cac44ad-1835-487e-b6d0-1483d724bb5e2026-05-12WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANCardinal Health 107, LLC9cfb1abb-98c4-4e90-8dd7-fcffc112f9882026-05-12WarningsExact identifier
application number: M012
Nasal Decongestant PE and Pain Relief Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLWinCo Foods, LLCfab51b36-1c2e-4c97-932c-dacfaf55935a2026-05-11WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Companycad5da8c-65a6-44c4-a4c7-38f2c7fe43aa2026-05-11WarningsExact identifier
application number: M012
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
application number: M012
Device - NebuClear MD Hand-held Rubber Bulb NebulizerDEVICE - HAND-HELD RUBBER BULB NEBULIZERBlue Echo Care LLC43e0a646-be57-1024-e063-6394a90a43e42026-05-11WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED1efd1778-7ab1-4797-98c5-4637940ee3ec2026-05-11WarningsExact identifier
application number: M012
DayTime High Blood Pressure Cold and Flu Relief Liquid filled SoftgelsACETAMINOPHEN,DEXTROMETHROPHAN HBRAptaPharma Inc.0380035e-44d5-44ea-9d1c-d57a1de651882026-05-10WarningsExact identifier
application number: M012
Night Time Cold and Flu relief liquid filled softgelsACETAMINOPHEN,DEXTROMETHROPHAN HBR,DOXYLAMINE SUCCINATEAptaPharma Inc.d61e2186-8b59-45f9-96ec-83430a0fe0cb2026-05-10WarningsExact identifier
application number: M012
Maximum Strength Tussin DM Liquid filled SoftgelsDEXTROMETHORPHAN HBR, GUAIFENESINAptaPharma Inc.39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f12026-05-10WarningsExact identifier
application number: M012
Day-Time Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.c0dc613c-7f4e-4733-b2b6-6ba20e8fb83c2026-05-10WarningsExact identifier
application number: M012
Daytime Cold and Flu Relief Liquid Filled SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAptaPharma Inc.c078efb5-d30e-4dd1-a600-6e827390df762026-05-10WarningsExact identifier
application number: M012
DM Max CONGESTION and COUGHDEXTROMETHORPHAN HBR, GUAIFENESINDeMoulas Market Basketb12e26b2-79e4-45a5-9a90-4630f92457d02026-05-09WarningsExact identifier
application number: M012
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Companyfac55d76-457f-4258-9cc8-6edae539cada2026-05-08WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyVee Inc5a0ef8ae-f6d5-4388-b4da-6b7f025160b22026-05-08WarningsExact identifier
application number: M012
Halls Variety Pack Mentholyptus Honey Lemon CherryMENTHOLMondelez Global LLC512a9a2e-6160-80d1-e063-6394a90aeff02026-05-08WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5150ff85-85bb-9cd9-e063-6294a90a11442026-05-08WarningsExact identifier
application number: M012
Dr. Simi Children s CoughDEXTROMETHORPHAN HBR, GUAIFENESINFarmacias De Similares TX LLC5151740a-8270-7bb5-e063-6294a90ae3872026-05-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNccada339-656c-a461-e053-2a95a90a34794
1001084Zicam Congestion Relief 0.05 % Nasal SprayPSNccada339-656c-a461-e053-2a95a90a34794
1001084oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Zicam Sinus Relief]SBDccada339-656c-a461-e053-2a95a90a34794
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDccada339-656c-a461-e053-2a95a90a34794
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYccada339-656c-a461-e053-2a95a90a34794
1001084Zicam Extreme Congestion Relief 0.05 % Nasal SpraySYccada339-656c-a461-e053-2a95a90a34794
1001084Zicam Sinus Relief 0.05 % Nasal SpraySYccada339-656c-a461-e053-2a95a90a34794
1001084Zicam Sinus Relief 0.5 MG/ML Nasal SpraySYccada339-656c-a461-e053-2a95a90a34794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10237-464-15102370464151 BOTTLE, PLASTIC in 1 CARTON (10237-464-15) / 15 mL in 1 BOTTLE, PLASTIC2021-10-010000-00-00NoNoCurrent