Triacting Daytime Cold Cough

Product NDC
21130-378
Requested package NDC
21130-378-04
11-digit product format
211300378
Labeler code
21130
Product ID
21130-378_ca36d61c-c70a-476a-8a9b-7cb9a48500ad
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Phenylephrine HCl
Dosage form
SYRUP
Route
ORAL
Labeler
Safeway, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-05-31
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5 mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage21130-37821130-378-04DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-378-04Triacting Daytime Cold CoughChildrens1 in 1 BOXSYRUP15
21130-378-04Triacting Daytime Cold CoughChildrens118 mL in 1 BOTTLE, PLASTICSYRUP1185

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
MALTITOLINACTIVE INGREDIENTD65DG142WKTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-378TRIACTING DAYTIME COLD COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [SAFEWAY, INC.]5Legacy NDC, 2 package rows20240517_2b6a175f-238a-48d9-b99b-5e11fe44d359.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1535366dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SuspensionPSN2b6a175f-238a-48d9-b99b-5e11fe44d3595
1535366dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SuspensionSCD2b6a175f-238a-48d9-b99b-5e11fe44d3595
1535366dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SuspensionSY2b6a175f-238a-48d9-b99b-5e11fe44d3595

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-378-04211300378041 BOTTLE, PLASTIC in 1 BOX (21130-378-04) > 118 mL in 1 BOTTLE, PLASTIC2015-05-310000-00-00NoNoCurrent