FDA.reportPublic FDA data

NDC 63629-8616-01 - Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63629-8616
Requested NDC
63629-8616-01
Package NDCs from labels
63629-8616-1, 63629-8616-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-10-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALCOHOL - Bryant Ranch PrepackBryant Ranch Prepack2024-10-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8616-1Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide473 mL in 1 BOTTLE, PLASTICSYRUP473104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8616BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20241006_4368822d-2779-4fb2-9ca9-f020b8934dc5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8616-1ML - Milliliter63629-86166dc2c35c-d2d3-4eee-b5b9-c7c6de2436e312023-08-08

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 1 of 282 · 5,638 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dehydrated AlcoholALCOHOLAvenacy, LLC90e92d21-9821-4132-b17d-d98d523f12e82026-07-31Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
WhiskCare 373ALCOHOLWhisk Products, Inc.57d5cd5d-8597-ce66-e063-6394a90a00472026-07-30WarningsExact identifier
unii: 3K9958V90M
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
unii: 9D2RTI9KYH
WhiskCare 373ALCOHOLWhisk Products, Inc.cce95a6a-1188-4c69-8f20-4a1670c4c09b2026-07-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 4pk - Fresh Gingerbread/Spiced Cranberry/Vanilla Heaven/Pistachio BruleeALCOHOLShenzhen Lantern Scicence Co.,Ltd.57bd148e-f9eb-dfb6-e063-6394a90a1e122026-07-29WarningsExact identifier
unii: 3K9958V90M
ADVIL COLD AND SINUSIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLC0da9ed22-bfb4-d61b-110b-0c7760332a982026-07-29WarningsExact identifier
unii: 6V9V2RYJ8N
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
unii: 9D2RTI9KYH
Smart Care Hand Sanitizer 4pk - Fresh Calming Lavender/Sweet Citrus/Coconut Breeze/ Cucumber MelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.57cb54f7-07be-524f-e063-6294a90a2c942026-07-29WarningsExact identifier
unii: 3K9958V90M
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
unii: 9D2RTI9KYH
RUGBY MUCUS RELIEF DM ERDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRugby Laboratories8090d561-0478-435d-ad6f-2334e1823bc32026-07-28WarningsExact identifier
unii: 9D2RTI9KYH
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
It Bag Vanilla Sugar Hand SanitizerALCOHOLScent Theory Products LLC57adcf08-9785-016d-e063-6294a90aa8d42026-07-28WarningsExact identifier
unii: 3K9958V90M
It Bag Cherry Kiss Hand SanitizerALCOHOLScent Theory Products LLC57adec54-6099-0694-e063-6394a90a4a0f2026-07-28WarningsExact identifier
unii: 3K9958V90M
It Bag Strawberry Love Hand SanitizerALCOHOLScent Theory Products LLC57adfb22-cb7a-39e7-e063-6294a90a30792026-07-28WarningsExact identifier
unii: 3K9958V90M
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
unii: 6V9V2RYJ8N
Smart Care Hand Sanitizer with Pouch-Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.57b6f063-9afa-94c9-e063-6394a90a2c352026-07-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Lavender VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.57b7250c-49cd-3076-e063-6294a90ab7572026-07-28WarningsExact identifier
unii: 3K9958V90M
Magicare alcohol hand sanitizing wipesALCOHOL HAND SANITIZING WIPESGuangzhou Baihua Co., Ltd57b7531b-77f7-f63b-e063-6394a90aa81c2026-07-28WarningsExact identifier
unii: 3K9958V90M
Magicare alcohol hand sanitizing wipesALCOHOL HAND SANITIZING WIPESGuangzhou Baihua Co., Ltd57b7b74e-6df9-4384-e063-6394a90a09c42026-07-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Fig VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.57b7b91f-1874-f2f0-e063-6294a90a40602026-07-28WarningsExact identifier
unii: 3K9958V90M