Home NDC 51316-485 Allergy Plus Congestion Relief
Product NDC 51316-485
11-digit product format 513160485
Labeler code 51316
Product ID 51316-485_f605920f-a072-4f47-bc0b-0c1c90a4469d
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-08-09
Marketing end 2027-10-31
Substance DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 25; 10 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
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 Congestion Relief Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1052928 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 51316-485-08 Allergy Plus Congestion Relief 2 in 1 CARTON TABLET, FILM COATED 2 6 51316-485-08 Allergy Plus Congestion Relief 12 in 1 BLISTER PACK TABLET, FILM COATED 12 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-485 ALLERGY PLUS CONGESTION RELIEF (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] 4 Current NDC, Legacy NDC, 2 package rows 20240825_0d2cf481-622f-4262-b0bd-c38fe5de6721.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 51316-485-08 51316048508 2 BLISTER PACK in 1 CARTON (51316-485-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2022-08-09 2027-10-31 No No Current