Allergy Multi-Symptom

Product NDC
55910-455
11-digit product format
559100455
Labeler code
55910
Product ID
55910-455_9519eb30-afa8-45b9-a854-87e8d7616d59
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOLGENCORP, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-06-28
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 2; 5 mg/1; mg/1; mg/1
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
2027-12-31
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
Allergy Multi-Symptom
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
CHLORPHENIRAMINE MALEATE2 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
V1Q0O9OJ9ZInternal 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
1046781Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fae1499a-7029-4208-8436-4d330347b915Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-455-08Allergy Multi-Symptom2 in 1 CARTONTABLET, FILM COATED214
55910-455-08Allergy Multi-Symptom12 in 1 BLISTER PACKTABLET, FILM COATED1214

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-455ALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]13Current NDC, Legacy NDC, 2 package rows20240619_fae1499a-7029-4208-8436-4d330347b915.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 27 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC3270f369-7a40-186d-e063-6394a90a85262026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCfe44d1ee-1e03-b74f-e053-6294a90a8bb42026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC31ac6883-ffcd-39de-e063-6294a90a52dd2026-05-19WarningsExact identifier
application number: M012
MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC325b41e1-f8d2-02ee-e063-6394a90aafff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC326f1fd3-73ab-e515-e063-6294a90ab2222026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC6c85df30-a601-4de6-9fd6-818265d799ff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7050b583-c09b-4457-9a9c-70c0923b62c02026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC27312ee4-d1f4-4a95-9c45-91fa5a01f5ba2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Daytime Pain, Headache, and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC37de53a7-5546-3804-e063-6294a90a0fb52026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC36b07e49-c72c-45e5-e063-6394a90a804a2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Clear and Cool Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2ee95e17-bd94-d717-e063-6294a90a21732026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Sinus Pressure Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2eeafd83-230c-af92-e063-6294a90a984e2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Congestion and Headache Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7017328-f8af-4601-9232-dc1104feaa0a2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC32375b12-75ed-d605-e063-6294a90ad0042026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC07da45b5-d05e-41b1-b233-f7034d556a8d2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and Pain Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCad4e0e4d-cc1f-4176-835f-3ba76564c6342026-05-19WarningsExact identifier
application number: M012
Childrens Mucinex Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC60daf6e2-ded8-44e6-bd8d-9d221384adde2026-05-19WarningsExact identifier
application number: M012
Mucinex Childrens Mini Melts Cold and FluACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC401fe0a0-ec97-5248-e063-6394a90af27f2026-05-19WarningsExact identifier
application number: M012
Childrens Cough and Congestion, Childrens Cold and Cough Day, NightDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINWALMART INC.312ae879-1124-40a4-b2ba-3f30708400212026-05-19WarningsExact identifier
application number: M012
GOOD SENSE DAYTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2597e84c-18b4-41a9-8e6a-ff0c4c1f06122026-05-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSNfae1499a-7029-4208-8436-4d330347b91514
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDfae1499a-7029-4208-8436-4d330347b91514
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSYfae1499a-7029-4208-8436-4d330347b91514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-455-08559100455082 BLISTER PACK in 1 CARTON (55910-455-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-06-280000-00-00NoNoCurrent