Home NDC 55910-464 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 Ingredient Strength ACETAMINOPHEN 325 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1233575 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55910-464-08 Allergy Plus Sinus Headache 12 in 1 BLISTER PACK TABLET, FILM COATED 12 19 55910-464-08 Allergy Plus Sinus Headache 2 in 1 CARTON TABLET, FILM COATED 2 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALLERGY/SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET [DOLGENCORP, LLC] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-464 ALLERGY PLUS SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC] 18 Current NDC, Legacy NDC, 2 package rows 20240719_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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55910-464-08 55910046408 2 BLISTER PACK in 1 CARTON (55910-464-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-06-15 0000-00-00 No No Current