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 155 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equaline nasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI07e0328e-1912-4f25-9e1e-9482d4665be02024-09-07WarningsExact identifier
application number: M012
Benadryl Allergy EXTRA STRENGTHDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCdd0a8069-18d8-5696-e053-2995a90a2f222024-09-06WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEPAI Holdings, LLC88d0994c-4270-4408-8837-bd97510b21182024-09-06WarningsExact identifier
application number: M012
QCH Maximum Strength Mucus Relief 617DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association Inc.a1c5c15e-0f3a-47d3-b9ed-1e00184175142024-09-06WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Nighttime Soft ChewsACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC6ba64bbe-7599-406a-9187-737c0f8c1c2a2024-09-05WarningsExact identifier
application number: M012
Cough Relief NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)344282fc-3bd1-4f49-9bd1-08c5a58d1f732024-09-05WarningsExact identifier
application number: M012
Equate NasalPHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc95ef1819-edc3-4dda-8514-85b61538cc722024-09-04WarningsExact identifier
application number: M012
Up and up nasalOXYMETAZOLINE HYDROCHLORIDETarget Corporation0c246c11-eadd-4ac6-bd58-5fdb151e06d62024-09-04WarningsExact identifier
application number: M012
Exchange Select NasalOXYMETAZOLINE HYDROCHLORIDEArmy & Air Force Exchange Serviceaafa9163-f08e-48c9-9ca1-7b72f67d007d2024-08-31WarningsExact identifier
application number: M012
nasal 12 hourOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Ince9ee03db-a070-4c2b-ac61-7fd22bab27952024-08-31WarningsExact identifier
application number: M012
dg health nasalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLC42b58928-e8e5-49e4-b49e-498d77d64fcd2024-08-28WarningsExact identifier
application number: M012
nasal mistOXYMETAZOLINE HCLCVS Pharmacyb71c557a-eb93-40d1-87c4-847f5468fc1e2024-08-28WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HCLKroger Company0a24d98a-5950-49de-8b77-ea880b08d2c52024-08-28WarningsExact identifier
application number: M012
basic care no drip nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLC96e018e2-e0b5-4802-a4a1-73a73d5740822024-08-28WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HCLTopco Associates LLCb5434599-5485-4949-9d76-b1ef3ad17c1a2024-08-28WarningsExact identifier
application number: M012
basic care no drip nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCb15eb271-7842-495b-aa0f-9b20def86dc12024-08-28WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCf1dd78e0-f700-4469-85d6-18cc299e87462024-08-28WarningsExact identifier
application number: M012
equaline nasalOXYMETAZOLINE HCLUnited Natural Foods, Inc. dba UNFI69308693-a094-42a9-a041-e73647a25cc12024-08-27WarningsExact identifier
application number: M012
signature care nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafewayf9ac80d1-3753-412b-a407-18a6b50e5d1c2024-08-27WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.20ac6010-84f4-eeff-e063-6294a90a50a72024-08-27WarningsExact 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