FDA.reportPublic FDA data

Allergy Plus Sinus Headache

Product NDC
55910-464
11-digit product format
559100464
Labeler code
55910
Product ID
55910-464_c3ce7278-9eab-4f9b-8cc4-d79e4b090da6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOLGENCORP, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-06-15
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 12.5; 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 Plus Sinus Headache
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE12.5 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
TC2D6JAD40Internal 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
1233575Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2eacb1b-8b29-41ec-828a-c1f902ac0934Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-464-08Allergy Plus Sinus Headache12 in 1 BLISTER PACKTABLET, FILM COATED1219
55910-464-08Allergy Plus Sinus Headache2 in 1 CARTONTABLET, FILM COATED219

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
ACETAMINOPHENACTIVE MOIETY362O9ITL9DALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-464ALLERGY PLUS SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]18Current NDC, Legacy NDC, 2 package rows20240719_f2eacb1b-8b29-41ec-828a-c1f902ac0934.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 2 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
application number: M012
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
application number: M012
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
application number: M012
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINRARITAN PHARMACEUTICALS INC4898b1c2-55ef-4589-982b-2279c01707e52026-09-08WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association, Inc.2a7afe03-3c34-4e30-827e-b3bb2568cb972026-09-08WarningsExact identifier
application number: M012
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation71845bf9-8981-4ca0-a62c-dbef102b1b022026-09-04WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
application number: M012
NostrillaOXYMETAZOLINE HYDROCHLORIDEInsight Pharmaceuticals LLC86217847-8e2b-48cc-b289-4987fd3aa7c32026-09-04WarningsExact identifier
application number: M012
tussin cough chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation86fc3723-5fc5-4de5-bd04-7774c2abe5392026-09-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLCed576bf1-3949-423e-af2e-e4b1a3839b212026-09-04WarningsExact identifier
application number: M012
tussin nighttime coughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporation80d51af8-3a7b-4d22-8d4f-df5f919130472026-09-04WarningsExact identifier
application number: M012
NO MORE NOSEBLEEDOXYMETAZOLINE HYDROCHLORIDEDR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.69d3f1fe-b476-4f84-8c5e-94957b74b46c2026-09-04WarningsExact identifier
application number: M012
Ultra Fine Mist Sinus ReliefOXYMETAZOLINE HYDROCHLORIDEDOLGENCORP, INC.5f134840-2465-4585-a85d-08d746f76f7a2026-09-03WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATEFamily Dollar (FAMILY WELLNESS)22918db6-9096-4eb8-a742-aaa2dd5c31da2026-09-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233575acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral TabletPSNf2eacb1b-8b29-41ec-828a-c1f902ac093419
1233575acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDf2eacb1b-8b29-41ec-828a-c1f902ac093419
1233575acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral TabletSYf2eacb1b-8b29-41ec-828a-c1f902ac093419
1233575APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYf2eacb1b-8b29-41ec-828a-c1f902ac093419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-464-08559100464082 BLISTER PACK in 1 CARTON (55910-464-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-06-150000-00-00NoNoCurrent