FDA.reportPublic FDA data

Allergy and Sinus Headache

Product NDC
55301-464
11-digit product format
553010464
Labeler code
55301
Product ID
55301-464_ce2e4f56-2f5d-4fa6-ba3e-51c471fb771b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl 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
2005-06-15
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 and 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
91268cd0-c151-4744-a715-a57af3f3a314Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-464-08Allergy and Sinus Headache12 in 1 BLISTER PACKTABLET, FILM COATED1216
55301-464-08Allergy and Sinus Headache2 in 1 CARTONTABLET, FILM COATED216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-464ALLERGY AND SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]15Current NDC, Legacy NDC, 2 package rows20250315_91268cd0-c151-4744-a715-a57af3f3a314.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 135 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c62024-11-21WarningsExact identifier
application number: M012
Dextromethorphan HBr 15 mgDEXTROMETHORPHAN HBRHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.028b025e-2dde-4bef-ba7b-61774e855b4b2024-11-21WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEPuraCap Pharmaceutical LLC856cb3c3-8f32-4285-8c13-25f01779a31a2024-11-21WarningsExact identifier
application number: M012
Night Time Severe Cold and Flu ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC3375a059-2939-438e-92b5-a7f1952bbb222024-11-21WarningsExact identifier
application number: M012
NiteTime Cold/Flu, Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc9033bf94-f444-4488-b717-050d04dee3882024-11-21WarningsExact identifier
application number: M012
Day and Night Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.4b554ce8-9a6a-444f-b5ea-63359bbc06532024-11-21WarningsExact identifier
application number: M012
Day Severe Cold and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores, Inc.7492b381-9eca-4b07-b356-63fdaea14f812024-11-21WarningsExact identifier
application number: M012
Severe sinus Congestion ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLCe173bec9-14df-4535-a023-47d8cda8d4ec2024-11-21WarningsExact identifier
application number: M012
COLD FLU and SORE THROAT RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEFOODHOLD U.S.A., LLC1161e5dc-0677-4fb9-964f-971a508098b62024-11-21WarningsExact identifier
application number: M012
Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERetail Business Services, LLCfc8c70d6-6be5-4f12-84b0-125fc82149ec2024-11-21WarningsExact identifier
application number: M012
12 Hour Original Nasal DecongestantNASAL SPRAYWinCo Foods LLCb3b6065a-56da-45e9-b89d-f6553bc181c92024-11-21WarningsExact identifier
application number: M012
Family Wellness Oxymetazoline Sinus SevereOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)13237d31-c60a-49f8-9b96-4414cf766a082024-11-21WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5b55d1df-275b-40d8-bde3-fc43313b7eb32024-11-20WarningsExact identifier
application number: M012
Halls Green AppleMENTHOLMondelez Global LLC1bb8dcb2-c3a8-a64e-e063-6294a90ae4a22024-11-20WarningsExact identifier
application number: M012
Halls BlueberryMENTHOLMondelez Global LLC275a6935-ea44-486e-e063-6394a90ae19a2024-11-20WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYWalgreens Company234bd567-4e3c-419f-a000-fdfc28cafc8b2024-11-20WarningsExact identifier
application number: M012
NICE Assorted Cough DropsMENTHOLLeosons Overseas Corp96db0f37-41cc-1ebd-e053-2a95a90a32152024-11-19WarningsExact identifier
application number: M012
Nice Cherry Cough DropsMENTHOLLeosons Overseas Corp98e52604-6e41-6408-e053-2995a90a6bc82024-11-19WarningsExact identifier
application number: M012
NICE Citrus Cough DropsMENTHOLLeosons Overseas Corp96d9527d-9bf9-ce82-e053-2995a90aff0c2024-11-19WarningsExact identifier
application number: M012
NICE Menthol Cough DropsMENTHOLLeosons Overseas Corp96d77897-475c-482c-e053-2995a90a2da42024-11-19WarningsExact 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 TabletPSN91268cd0-c151-4744-a715-a57af3f3a31416
1233575acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD91268cd0-c151-4744-a715-a57af3f3a31416
1233575acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral TabletSY91268cd0-c151-4744-a715-a57af3f3a31416
1233575APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY91268cd0-c151-4744-a715-a57af3f3a31416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-464-08553010464082 BLISTER PACK in 1 CARTON (55301-464-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-06-150000-00-00NoNoCurrent