FDA.reportPublic FDA data

DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula

Product NDC
51013-168
11-digit product format
510130168
Labeler code
51013
Product ID
51013-168_277c121e-8fc3-f080-e063-6294a90a80ea
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride
Dosage form
KIT
Labeler
PuraCap Pharmaceutical LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-15
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1086997, 1297288, 2634363

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-168-08DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-168DG DAY TIME COLD AND FLU FORMULA AND NIGHT TIME COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [PURACAP PHARMACEUTICAL LLC]3Current NDC, Legacy NDC, 1 package rows20241123_cb68eef0-b027-4bf1-b78f-f31844a8c06c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634363{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCKcb68eef0-b027-4bf1-b78f-f31844a8c06c3
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSNcb68eef0-b027-4bf1-b78f-f31844a8c06c3
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSNcb68eef0-b027-4bf1-b78f-f31844a8c06c3
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNcb68eef0-b027-4bf1-b78f-f31844a8c06c3
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDcb68eef0-b027-4bf1-b78f-f31844a8c06c3
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDcb68eef0-b027-4bf1-b78f-f31844a8c06c3
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSYcb68eef0-b027-4bf1-b78f-f31844a8c06c3
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYcb68eef0-b027-4bf1-b78f-f31844a8c06c3
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYcb68eef0-b027-4bf1-b78f-f31844a8c06c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-168-08510130168081 KIT in 1 CARTON (51013-168-08) * 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 kit2016-06-150000-00-00NoNoCurrent