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 87 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens Allergy Dye Free Wal DrylDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN CO.4e64e040-1662-4dc9-b33f-3e119e0b3f7b2025-11-25WarningsExact identifier
application number: M012
WalgreenNASALWALGREENS COd38f8406-d7b9-472c-a472-58968bbdb9932025-11-25WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC780907b8-34ba-4ec8-bcdf-b2a31bd111df2025-11-25WarningsExact identifier
application number: M012
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCd13efbcd-1277-45d0-8389-1ba0337f7a242025-11-25WarningsExact identifier
application number: M012
Childrens Robitussin Elderberry Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCfe903448-b422-42e0-b05b-aeb3e5481e3c2025-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC1d4fcb76-22d1-7292-e063-6394a90af9202025-11-25WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGH Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLCf22248b7-7abd-4df7-a986-dae357ebe8f12025-11-25WarningsExact identifier
application number: M012
ROBITUSSIN Nighttime Cough DM Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHaleon US Holdings LLC39468746-e06d-4849-9d06-9af4d14351b02025-11-25WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.4478fd51-bae3-6108-e063-6394a90a07ca2025-11-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INC.395bb39a-e26f-f4f2-e063-6394a90ae7212025-11-25WarningsExact identifier
application number: M012
day timeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEH E Beaf3af6a-de5b-43fe-83ff-9641646e0f6b2025-11-25WarningsExact identifier
application number: M012
MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid GelsACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERB Health (US) LLC38571853-992f-9998-e063-6394a90a85812025-11-24WarningsExact identifier
application number: M012
Basic Care Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLCe19b561c-fb76-4355-a306-d3dc46930bf22025-11-24WarningsExact identifier
application number: M012
Sinus DecongestionPSEUDOEPHEDRINE HCLKroger Company73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c2025-11-24WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCICardinal Health (Leader) 7000014c507df-fbac-4a09-a66c-b91c2abbf5502025-11-24WarningsExact identifier
application number: M012
Severe Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCIFamily Dollar (FAMILY WELLNESS)e5c90d6e-70aa-4886-bc81-293e0dcf56382025-11-24WarningsExact identifier
application number: M012
Throat Coat Eucalyptus MintMENTHOLTraditional Medicinals, Inc.a7a86f1b-30e8-6f5d-e053-2a95a90a2a822025-11-21WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.4538248f-11cc-d6b2-e063-6294a90a652c2025-11-21WarningsExact identifier
application number: M012
up and up Daytime Nighttime Childrens Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationb8a4da0b-e4d3-48e6-b699-cb56c7b67ed72025-11-20WarningsExact identifier
application number: M012
Supress DX Pediatric DropsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVISddb95436-7806-4086-af4d-18a6625b5c832025-11-20WarningsExact 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