FDA.reportPublic FDA data

Theraflu ExpressMax

Product NDC
0067-8129
11-digit product format
000678129
Labeler code
0067
Product ID
0067-8129_131827e6-0141-cf1d-e063-6294a90ae248
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form
SYRUP
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-15
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650; 25; 10 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [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
Theraflu ExpressMax
Brand name suffix
Nighttime Severe Cold and Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/30mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1298348Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8129-08Theraflu ExpressMaxNighttime Severe Cold and Cough245.5 mL in 1 BOTTLESYRUP245.57
0067-8129-08Theraflu ExpressMaxDaytime Nighttime Value Pack245.5 mL in 1 BOTTLESYRUP245.5 mL650 mg in 30mL5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-8129-08ML - Milliliter0067-8129d2541d5a-5905-40e7-bf8a-81fdf97222a812016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
MALTITOLINACTIVE INGREDIENTD65DG142WKTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RTHERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
MALTITOLINACTIVE INGREDIENTD65DG142WKTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTHERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8129THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 1 package rows20240308_f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb.zip
0067-8129THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC20240411_9736ad4c-8c2e-421f-b023-f91b72d2828b.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 122 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Kroger DayTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEThe Kroger Co.2499210b-c162-76b9-e063-6294a90adbc32025-01-17WarningsExact identifier
application number: M012
Childrens Multi Symptom Cold Very BerryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS2a849ae9-338f-4642-e063-6394a90a1ca42025-01-17WarningsExact identifier
application number: M012
Kroger NightTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Co.24a73de3-e9eb-4cd4-e063-6394a90aa2632025-01-17WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORALEverpharm LLCd7aaf874-69ac-49cf-93be-6d4a38b9a5572025-01-16WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)204a7fc4-142d-45fd-8a77-0612857132be2025-01-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298348acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNf5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb7
1298348acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDf5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb7
1298348acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYf5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb7
1298348acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYf5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb7
1298348APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSYf5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb7
1803669{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } PackGPCK9736ad4c-8c2e-421f-b023-f91b72d2828b5
18036691 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) PackPSN9736ad4c-8c2e-421f-b023-f91b72d2828b5
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN9736ad4c-8c2e-421f-b023-f91b72d2828b5
1298348acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN9736ad4c-8c2e-421f-b023-f91b72d2828b5
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD9736ad4c-8c2e-421f-b023-f91b72d2828b5
1298348acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD9736ad4c-8c2e-421f-b023-f91b72d2828b5
18036691 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution) PackSY9736ad4c-8c2e-421f-b023-f91b72d2828b5
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY9736ad4c-8c2e-421f-b023-f91b72d2828b5
1298348acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY9736ad4c-8c2e-421f-b023-f91b72d2828b5
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY9736ad4c-8c2e-421f-b023-f91b72d2828b5
1298348acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY9736ad4c-8c2e-421f-b023-f91b72d2828b5
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSY9736ad4c-8c2e-421f-b023-f91b72d2828b5
1298348APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSY9736ad4c-8c2e-421f-b023-f91b72d2828b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-8129-0800067812908245.5 mL in 1 BOTTLE (0067-8129-08) 245.5 ml2015-07-150000-00-00NoNoCurrent