Home NDC 0280-0506 Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night
Product NDC 0280-0506
11-digit product format 002800506
Labeler code 0280
Product ID 0280-0506_45266d30-bb3b-21f8-e063-6294a90a29cf
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride, Guaifenesin
Dosage form KIT
Route ORAL
Labeler Bayer HealthCare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-05-30
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 Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night
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 1297288 Internal RxNorm lookup 1432488 Internal RxNorm lookup 1927849 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 0280-0506-20 Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night 1 in 1 CARTON KIT 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0506 ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION DAY AND NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN) KIT [BAYER HEALTHCARE LLC.] 5 Current NDC, Legacy NDC, 1 package rows 20231205_5278a128-41ec-4494-e054-00144ff8d46c.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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1927849 {1 (acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack GPCK 5278a128-41ec-4494-e054-00144ff8d46c 6 1927849 1 daytime (acetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 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) Pack PSN 5278a128-41ec-4494-e054-00144ff8d46c 6 1432488 acetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule PSN 5278a128-41ec-4494-e054-00144ff8d46c 6 1297288 acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule PSN 5278a128-41ec-4494-e054-00144ff8d46c 6 1432488 acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule SCD 5278a128-41ec-4494-e054-00144ff8d46c 6 1297288 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule SCD 5278a128-41ec-4494-e054-00144ff8d46c 6 1927849 1 daytime (acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) Pack SY 5278a128-41ec-4494-e054-00144ff8d46c 6 1432488 APAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule SY 5278a128-41ec-4494-e054-00144ff8d46c 6 1297288 APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule SY 5278a128-41ec-4494-e054-00144ff8d46c 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0280-0506-20 00280050620 1 KIT in 1 CARTON (0280-0506-20) * 2 BLISTER PACK in 1 CARTON / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 kit 2017-05-30 0000-00-00 No No Current