FDA.reportPublic FDA data

Ninjacof

Product NDC
23359-032
11-digit product format
233590032
Labeler code
23359
Product ID
23359-032_47183553-1992-6cd0-e063-6394a90a48dc
Type
HUMAN OTC DRUG
Nonproprietary name
chlophedianol hcl and pyrilamine maleate
Dosage form
SOLUTION
Route
ORAL
Labeler
Centurion Labs, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-15
Substance
CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE
Active strength
12.5; 12.5 mg/5mL; mg/5mL
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
Ninjacof
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOPHEDIANOL HYDROCHLORIDE12.5 mg/5mL
PYRILAMINE MALEATE12.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
69QQ58998YInternal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1593749Internal RxNorm lookup
1593756Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2bca40f-9c27-ec8b-2ff0-ef9847ba2037Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23359-032-04Ninjacof120 mL in 1 BOTTLESOLUTION12024
23359-032-10Ninjacof10 mL in 1 BOTTLESOLUTION1024
23359-032-16Ninjacof473 mL in 1 BOTTLESOLUTION47324

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23359-032-16ML - Milliliter23359-032adf69f2b-d87c-4fb4-a599-c82733d748ac12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOPHEDIANOL HYDROCHLORIDEACTIVE INGREDIENT69QQ58998YNINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]3
Pyrilamine MaleateACTIVE INGREDIENTR35D29L3ZANINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]3
CHLOPHEDIANOLACTIVE MOIETY42C50P12APNINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]3
PyrilamineACTIVE MOIETYHPE317O9TLNINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]3
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TNINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]3
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQNINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3NINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]3
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHNINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]3
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRNINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]3
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4NINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]3
WaterINACTIVE INGREDIENT059QF0KO0RNINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23359-032NINJACOF (CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE) SOLUTION [CENTURION LABS, LLC]23Current NDC, Legacy NDC, 3 package rows20241228_e2bca40f-9c27-ec8b-2ff0-ef9847ba2037.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 37 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast DissolveASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.50762d7c-5efd-4f83-e063-6294a90abf7f2026-04-27WarningsExact identifier
application number: M012
Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.6427b418-89d1-4eac-b25b-0adfefc204fc2026-04-27WarningsExact identifier
application number: M012
Nighttime Sleep AidDIPHENHYDRAMINE HCLCare One (American Sales Company)bd5de3b3-7cb5-4403-b664-23ac70b9957f2026-04-27WarningsExact identifier
application number: M012
Leader Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leader333c7042-95b8-4d98-9df1-4287017afa362026-04-25WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDESportpharm LLCf2d55d1b-c3d4-4c35-b761-681ed50273bd2026-04-24WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLSportpharm LLC2c4e0d5e-958d-4274-876a-52126c795c0f2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50364a42-3333-51fe-e063-6394a90ab71e2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5036dc50-e95b-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
application number: M012
Cold and Flu Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdcb33d5f-87fa-4043-9b6d-36adec96796c2026-04-24WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLCardinal Health 107, LLCabc0e348-8532-4658-bd8c-d7dbe5a28c7d2026-04-23WarningsExact identifier
application number: M012
nitetime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Incc5535aaf-c029-48d8-97d1-105a49b5fd952026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.50228b3c-d54a-485d-e063-6394a90a44032026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu Severe Fast ChewablesCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5025a333-6378-bf59-e063-6394a90af4f02026-04-23WarningsExact identifier
application number: M012
POLY-HIST DMDEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBRPOLY PHARMACEUTICALS, INC.5025c99f-b946-e2e0-e063-6394a90a13fb2026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5026611c-93e7-8f90-e063-6394a90a7baa2026-04-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLCc9c1db0f-6ba4-433c-b0ce-e99e9351c0b02026-04-23WarningsExact identifier
application number: M012
Severe Cold and Flu Plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLCOSTCO WHOLESALE CORPORATION5180abbc-c6c4-4b82-b6e7-4504e3bcff0f2026-04-23WarningsExact identifier
application number: M012
Severe Cold and Flu Night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc4f963491-e1f0-494d-acb6-5f4d2b267d4a2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHf4b01827-7444-3bfc-e053-2a95a90aebed2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH,cfd43b8f-8064-6b88-e053-2a95a90a329e2026-04-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1593749chlophedianol HCl 12.5 MG / pyrilamine maleate 12.5 MG in 5 mL Oral SolutionPSNe2bca40f-9c27-ec8b-2ff0-ef9847ba203724
1593756Ninjacof 12.5 MG / 12.5 MG in 5 mL Oral SolutionPSNe2bca40f-9c27-ec8b-2ff0-ef9847ba203724
1593756chlophedianol hydrochloride 2.5 MG/ML / pyrilamine maleate 2.5 MG/ML Oral Solution [Ninjacof]SBDe2bca40f-9c27-ec8b-2ff0-ef9847ba203724
1593749chlophedianol hydrochloride 2.5 MG/ML / pyrilamine maleate 2.5 MG/ML Oral SolutionSCDe2bca40f-9c27-ec8b-2ff0-ef9847ba203724
1593749chlophedianol hydrochloride 12.5 MG / pyrilamine maleate 12.5 MG per 5 ML Oral SolutionSYe2bca40f-9c27-ec8b-2ff0-ef9847ba203724
1593756Ninjacof (chlophedianol hydrochloride 12.5 MG / pyrilamine maleate 12.5 MG) per 5 ML Oral SolutionSYe2bca40f-9c27-ec8b-2ff0-ef9847ba203724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23359-032-0423359003204120 mL in 1 BOTTLE (23359-032-04) 120 ml2017-09-190000-00-00NoNoCurrent
23359-032-102335900321010 mL in 1 BOTTLE (23359-032-10) 10 ml2017-09-180000-00-00NoNoCurrent
23359-032-1623359003216473 mL in 1 BOTTLE (23359-032-16) 473 ml2014-10-150000-00-00NoNoCurrent