FDA.reportPublic FDA data

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 13 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tukol Max Action Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEGenomma Lab USAcf0987a3-2c1d-4f40-8551-df9a8e08cd3d2026-08-03WarningsExact identifier
application number: M012
Pressure, Pain and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.7d42e164-86e9-4baa-a389-3271cf99920e2026-08-03WarningsExact identifier
application number: M012
DG Health Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp Inced754d5c-74e1-4dee-a5c5-10ccec1b81db2026-08-03WarningsExact identifier
application number: M012
RIGHT REMEDIES Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINStrive Pharmaceuticals Inc.51c4dcfb-8725-d547-e063-6394a90ac04c2026-07-31WarningsExact identifier
application number: M012
Stona for ChildrenACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.18f3d694-9dff-407e-a264-916dbd201f9a2026-07-31WarningsExact identifier
application number: M012
StonarhiniCHLORPHENIRAMINE MALEATE, PHENYLEPHRINESato Pharmaceutical Co., Ltd.cc353280-0b4c-418c-93fe-8501259550092026-07-31WarningsExact identifier
application number: M012
cold and flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEMeijer Distribution Inc5519e918-71cb-4430-ae57-e03cd5ac60022026-07-31WarningsExact identifier
application number: M012
Good Neighbor Pharmacy allergyDIPHENHYDRAMINE HYDROCHLORIDEAmerisource Bergen9819522f-f3db-4cb8-9680-423114ace2f62026-07-31WarningsExact identifier
application number: M012
Sinus Relief Daytime, NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation352b89b5-6995-4873-a103-e8f89074fdc92026-07-30WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HYDROCHLORIDEMeijer Distribution Incf1e83e43-011c-4470-bd55-fb2818a9fc842026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
TOPCARE NITE TIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLC905d1c5c-65c8-47a3-ad7a-61a4b4b98f0d2026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact 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