FDA.reportPublic FDA data

Allergy Multi-Symptom

Product NDC
55301-455
11-digit product format
553010455
Labeler code
55301
Product ID
55301-455_4b7865ff-4901-442a-95ec-4172c2203ec5
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
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
f311b56f-b959-4070-9b23-82c642dd98b8Available 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
55301-455-08Allergy Multi-Symptom2 in 1 CARTONTABLET, FILM COATED217
55301-455-08Allergy Multi-Symptom12 in 1 BLISTER PACKTABLET, FILM COATED1217

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-455ALLERGY MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]16Current NDC, Legacy NDC, 2 package rows20240823_f311b56f-b959-4070-9b23-82c642dd98b8.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 32 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC14c56f3d-67fd-45ef-a16b-f276047228832026-05-12WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Mucus and Congestion Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare, LLC.51a4195b-8776-964c-e063-6294a90aa0752026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3ba3548e-85e7-b4a6-e063-6394a90af84d2026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCfe7eeb71-e219-4c84-ac06-98c3a40b14dc2026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC6f8241d7-0f30-40b3-926b-861c57079f1d2026-05-12WarningsExact identifier
application number: M012
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51a45db8-2bee-6fd0-e063-6394a90ab5872026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Day Cold and Flu and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC19da539e-7b57-41d7-aad5-fc89a6705e202026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC182222b5-a852-4dbe-b05f-a41d898060212026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8a790eeb-7d7d-4a94-9103-6ed09c04d5962026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCdbdafbb4-f3c9-4042-b867-db4d06dc3d612026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd03ef2fd-1a08-42c0-b69d-fd4e4285ccd32026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC29571047-4c4b-44ca-8726-57c28308e8cf2026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain and Mucinex Nightshift SinusACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC75c6b92f-219f-4740-bb72-c02a927a21ff2026-05-12WarningsExact identifier
application number: M012
Mucinex Sinus-Max Day Pressure, Pain and Cough and Mucinex Nightshift Night Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCc746953f-4b7d-4e2a-9b85-96bd6901f5172026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCcea08797-1d53-4434-be1a-144f2ded5f9d2026-05-12WarningsExact identifier
application number: M012
Maximum Strength Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC2ef9d5de-e99e-4398-bf97-c7bef94498fa2026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Severe Congestion and Cough and Mucinex Nightshift Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCa401eb92-60b6-427d-a677-29371a3150be2026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCc902b4fc-c71c-4ef2-b5cb-6c2bd019acbc2026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC3ff4c4ea-7628-4d2b-a6e9-d994c25baef42026-05-12WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7c18e95-8d7b-4550-9a20-fc704a114adb2026-05-12WarningsExact 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 TabletPSNf311b56f-b959-4070-9b23-82c642dd98b817
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf311b56f-b959-4070-9b23-82c642dd98b817
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSYf311b56f-b959-4070-9b23-82c642dd98b817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-455-08553010455082 BLISTER PACK in 1 CARTON (55301-455-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-06-280000-00-00NoNoCurrent