FDA.reportPublic FDA data

Ninjacof

Product NDC
23359-032
Requested package NDC
23359-032-10
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 121 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UP AND UP NO DRIP NASALOXYMETAZOLINE HYDROCHLORIDETarget Corporation760d6d0f-00fc-40bc-858d-83a0827d139f2025-01-29WarningsExact identifier
application number: M012
Guaifenesin and DextromethorphanGUAIFENESIN AND DEXTROMETHORPHANMajor Pharmaceuticals51e48201-bb62-4e89-85eb-e4a416f935222025-01-29WarningsExact identifier
application number: M012
Severe Congestion and Cough MaxDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLBest Choice8c878e47-94f4-484f-bdd8-6d87ac2440d82025-01-28WarningsExact identifier
application number: M012
Cough and Cold TherapyCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088be461-7afc-586a-e063-6294a90a700b2025-01-27WarningsExact identifier
application number: M012
Cough and Cold Therapy For KidsCAMPHOR, MENTHOL, EUCALYPTUS OILEverlaan Organics Inc088df369-114c-db4f-e063-6394a90acfac2025-01-27WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a2025-01-26WarningsExact identifier
application number: M012
Walgreens Menthol Cough DropsMENTHOLWalgreens2c62f690-8dfb-d28e-e063-6394a90a45a22025-01-23WarningsExact identifier
application number: M012
Walgreens Cherry Cough DropsMENTHOLWalgreens2c65d836-e724-50d6-e063-6394a90a08272025-01-23WarningsExact identifier
application number: M012
Walgreens Honey Lemon Cough DropsMENTHOLWalgreens2c67424c-2fb0-cc15-e063-6394a90a02ca2025-01-23WarningsExact identifier
application number: M012
Pharmacys Prescription Analgesic GelMENTHOLAmerican Consumer Products Corp6f0725f2-833f-f3a0-e053-2a91aa0a39112025-01-23WarningsExact identifier
application number: M012
Pharmacys Prescription Vapor RubMENTHOLAmerican Consumer Products Corp6ef328ff-f5c3-515d-e053-2a91aa0a32d32025-01-23WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLBest Choice0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d2025-01-22WarningsExact identifier
application number: M012
GOOD REMEDIES Allergy Relief SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.26a02737-2cfd-769f-e063-6394a90af3522025-01-22WarningsExact identifier
application number: M012
PharbechlorCHLORPHENIRAMINE MALEATE 4MGUlai Health LLC6a1a5cef-e946-4ba8-9402-557c6adf45f92025-01-20WarningsExact identifier
application number: M012
PharbinexGUAIFENESIN 400MGUlai Health LLC4eafa81a-aeee-4c97-85d6-594902b109192025-01-20Exact identifier
application number: M012
Pharbinex-PEGUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MGUlai Health LLCe459bb83-b1d6-42fc-aa46-99ad117e61442025-01-20Exact identifier
application number: M012
Pharbinex-DMGUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MGUlai Health LLCaf80d10e-3fb2-405a-a803-1f876b8dcd102025-01-20Exact identifier
application number: M012
Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid GelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLBayer HealthCare LLC.34b2e77f-5d04-15a7-e054-00144ff8d46c2025-01-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange ZestASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a23a6db6-4585-2882-e053-2a95a90ab01a2025-01-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.fc754dff-cecd-fc6b-e053-6394a90ab3712025-01-17WarningsExact 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
23359-032-102335900321010 mL in 1 BOTTLE (23359-032-10) 10 ml2017-09-180000-00-00NoNoCurrent