FDA.reportPublic FDA data

Meijer Children Cough and Chest Congestion DM

Product NDC
79481-7470
11-digit product format
794817470
Labeler code
79481
Product ID
79481-7470_b87ec87c-b8d7-4836-b208-b127a9ec36e7
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
MEIJER DISTRIBUTION INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 mg/20mL; mg/20mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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
Meijer Children Cough and Chest Congestion DM
Brand name suffix
Grape Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN200 mg/20mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-7470-8Meijer Children Cough and Chest Congestion DMGrape Flavor118 mL in 1 BOTTLELIQUID1183
79481-7470-8Meijer Children Cough and Chest Congestion DMGrape Flavor1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-7470MEIJER CHILDREN COUGH AND CHEST CONGESTION DM GRAPE FLAVOR (DEXTROMETHORPHAN HBR AND GUAIFENESIN) LIQUID [MEIJER DISTRIBUTION INC]2Current NDC, 2 package rows20241023_9121804a-e5eb-46a2-a4a7-cc625be846d1.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 172 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEMajor Pharmaceuticalsbcc1a001-4176-485d-aaf0-2037ca65c6b82023-12-14WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEMajor Pharmaceuticalsedb49b17-06a7-4c25-bc7c-d62c1deac7f12023-12-13WarningsExact identifier
application number: M012
Family Wellness Oxymetazoline No DripOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)0c006b1c-8ab2-4b9c-8738-e7001c1bb47d2023-12-11WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORP0b1e230d-4354-bf61-e063-6394a90a2b2f2023-12-09WarningsExact identifier
application number: M012
Phenylephrine HCl Maximum StrengthPHENYLEPHRINE HCLA-S Medication Solutionsfcb769d0-aa45-48eb-acd0-2247b392f9fe2023-12-09WarningsExact identifier
application number: M012
Daytime and Nighttime Severe Honey Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0bf915af-a016-0a46-e063-6394a90aacf52023-12-08WarningsExact identifier
application number: M012
Maximum Strength Daytime Severe and Nighttime Cold and FluDAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, NIGHTTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCITARGET Corporation0bf9c0df-7676-3060-e063-6394a90a16c72023-12-08WarningsExact identifier
application number: M012
NazalNAPHAZOLINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.4d4043f8-5ed3-4027-beb6-687db13082022023-12-06WarningsExact identifier
application number: M012
Family Wellness OxymetazolineOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)8b4557d4-74a0-400f-ad7a-6d31473b3c672023-12-06WarningsExact identifier
application number: M012
Childrens Plus FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)1598e6f8-08ee-4216-a5ab-76cad37b09a72023-12-06WarningsExact identifier
application number: M012
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf2023-12-05WarningsExact identifier
application number: M012
Welmedix HomeCare PRO Extra Strength Rapid Rash ReliefPETROLATUM, ZINC OXIDEWelmedix LLC551e6cce-7adc-4e98-baff-2703b83d75262023-12-05WarningsExact identifier
application number: M012
Stona-SACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc12023-12-04WarningsExact identifier
application number: M012
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.afc95c82-18da-487b-b4bb-51e0be0378da2023-12-04WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYWalgreens Companya14643a1-3d91-491a-88d6-22dccde979382023-12-04WarningsExact identifier
application number: M012
TopCare Day Time SEVERE Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC14d53907-a4a2-4a0f-b2d6-33474945f9e12023-12-04WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLProficient Rx LP62934d0f-b23d-4c03-9d60-a7bad41f9b422023-12-01WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEProficient Rx LPb1c849e5-8003-4fd3-811d-6a927523e3532023-12-01WarningsExact identifier
application number: M012
Akin Expectorant Formula Strawberry BananaGUAIFENESINSouthern Sales & Service, Inc.b63b0133-d2da-432b-a154-9e77535bbef92023-11-29WarningsExact identifier
application number: M012
Akin Cough Formula DM Strawberry BananaDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSouthern Sales & Service, Inc.7a81efd8-775d-455e-860f-f3e3b369a0a72023-11-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSN9121804a-e5eb-46a2-a4a7-cc625be846d13
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCD9121804a-e5eb-46a2-a4a7-cc625be846d13
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSY9121804a-e5eb-46a2-a4a7-cc625be846d13
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSY9121804a-e5eb-46a2-a4a7-cc625be846d13
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSY9121804a-e5eb-46a2-a4a7-cc625be846d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79481-7470-8794817470081 BOTTLE in 1 CARTON (79481-7470-8) / 118 mL in 1 BOTTLE1 bottle2023-03-31NoNoCurrent