FDA.reportPublic FDA data

PhysiciansCare Allergy

Product NDC
0924-0091
11-digit product format
009240091
Labeler code
0924
Product ID
0924-0091_3e4c7d10-6f57-019f-e063-6294a90afd76
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Acme United Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-12-23
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
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
PhysiciansCare Allergy
Brand name suffix
Multi-Symptom Relief
Listing expiration
2026-12-31

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
fd101c27-6ba9-4cd3-baec-a354504c37a0Available 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
0924-0091-00PhysiciansCare AllergyMulti-Symptom Relief2 in 1 PACKETTABLET, FILM COATED212
0924-0091-01PhysiciansCare AllergyMulti-Symptom Relief50 in 1 CARTONTABLET, FILM COATED5012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZPHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UPHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]1
POLYETHYLENE GLYCOL 2000INACTIVE INGREDIENTHAF0412YITPHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-0091PHYSICIANSCARE ALLERGY MULTI-SYMPTOM RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [ACME UNITED CORPORATION]11Current NDC, Legacy NDC, 2 package rows20250210_fd101c27-6ba9-4cd3-baec-a354504c37a0.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 96 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quantum Health Bing Cherry FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.94d40c95-fa2b-42cf-b9f5-a5027d86401d2025-10-20WarningsExact identifier
application number: M012
Quantum Health Meyer Lemon and Honey FlavorMENTHOL, UNSPECIFIED FORMQuantum, Inc.fe780067-5a20-4d55-a108-91237cd9e5f42025-10-20WarningsExact identifier
application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)DIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.4157e680-37ac-eb4c-e063-6394a90a2a992025-10-17WarningsExact identifier
application number: M012
Norel ADACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCLU.S. PHARMACEUTICAL CORPORATION53d9ed3c-212d-4b12-ac35-8bd49382b49d2025-10-17WarningsExact identifier
application number: M012
Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED92c570ff-139f-49ff-a7bd-8a540ecc07c72025-10-17WarningsExact identifier
application number: M012
NoHist DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.6aafe912-28ff-442f-8e07-b3c5993ac9432025-10-16WarningsExact identifier
application number: M012
Signature Care OriginalOXYMETAZOLINE HYDROCHLORIDESAFEWAY, INC.f7ad687b-dcaf-928c-e053-6294a90a6abe2025-10-16WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)90ccb29c-9967-46cb-a409-e440344e1a1a2025-10-15WarningsExact identifier
application number: M012
Robitussin Childrens Honey Day Night DM Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCf9999875-3433-4052-a628-39539d3732162025-10-15WarningsExact identifier
application number: M012
Robitussin Day and Night Cough Relief Value PackDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATEHaleon US Holdings LLC4029eccd-5443-4ae2-9232-2a1d922798f82025-10-15WarningsExact identifier
application number: M012
EndaCof DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.c68ea55a-8b9a-4a70-8b5c-1a27366518132025-10-15WarningsExact identifier
application number: M012
DURATUSS DMDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEPoly Pharmaceuticals, Inc.413a3951-d704-f14b-e063-6394a90a06dc2025-10-15WarningsExact identifier
application number: M012
LoHist DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDELarken Laboratories, Inc.29730dab-fa09-4351-9b36-0359ba4f77442025-10-15WarningsExact identifier
application number: M012
M-END DMXDEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDER. A. McNeil Companyee1fae2e-3a21-4487-9989-c7620a4a70562025-10-15WarningsExact identifier
application number: M012
Chlo TussCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDER.A. McNeil Company43610aaa-8b94-40d5-ae09-3d75bd2317c82025-10-15WarningsExact identifier
application number: M012
Chlo HistCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATER. A. McNeil Companyd046f4ba-5753-4ed5-a924-0b66fd1167812025-10-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)6ca7372b-50c4-4b15-b133-fefa35525ade2025-10-15WarningsExact identifier
application number: M012
Extra Strength Sinus Relief Nasal DecongestantPHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH0d8a009c-30b5-4f12-90bd-f8aa1110243f2025-10-14WarningsExact identifier
application number: M012
Tussin DM Cough plus Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINCardinal Health 110, Inc. DBA LEADER9d11f443-c93d-44e8-b5a3-2677b7b112122025-10-14WarningsExact identifier
application number: M012
Rompe Pecho SFGUAIFENESINEfficient Laboratories, Inc.31ff48fc-9603-413c-ab7c-2598b3e08f9c2025-10-14WarningsExact 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 TabletPSNfd101c27-6ba9-4cd3-baec-a354504c37a012
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDfd101c27-6ba9-4cd3-baec-a354504c37a012
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSYfd101c27-6ba9-4cd3-baec-a354504c37a012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0924-0091-00009240091002 in 1 PACKETHistorical
0924-0091-010092400910150 PACKET in 1 CARTON (0924-0091-01) / 2 TABLET, FILM COATED in 1 PACKET (0924-0091-00) 50 packet2011-12-230000-00-00NoNoCurrent