Home NDC 51013-168 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 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 DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086997 Internal RxNorm lookup 1297288 Internal RxNorm lookup 2634363 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 51013-168-08 DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula 1 in 1 CARTON KIT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51013-168 DG DAY TIME COLD AND FLU FORMULA AND NIGHT TIME COLD AND FLU FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) KIT [PURACAP PHARMACEUTICAL LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241123_cb68eef0-b027-4bf1-b78f-f31844a8c06c.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 73 of 178 · 3,551 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 51013-168-08 51013016808 1 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 PACK 1 kit 2016-06-15 0000-00-00 No No Current