Home NDC 69168-319 Cold Multi-Symptom
Product NDC 69168-319
11-digit product format 691680319
Labeler code 69168
Product ID 69168-319_2c10d41f-cfbb-48dc-851f-b2959d12e075
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen,Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCI
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-12-23
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 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 Cold Multi-Symptom
Brand name suffix Night-time
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 CHLORPHENIRAMINE MALEATE 2 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086991 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69168-319-86 Cold Multi-SymptomNight-time 12 in 1 BLISTER PACK TABLET 12 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-319 COLD MULTI-SYMPTOM NIGHT-TIME (ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI) TABLET [ALLEGIANT HEALTH] 5 Current NDC, Legacy NDC, 1 package rows 20231115_3f020cf2-6011-4216-9b39-0b3dc5f0749c.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 5 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SurviveX Travel Med MOD CONVENIENCE KIT Intent Brands LLC 522da86b-cfd7-dd20-e063-6394a90a51c6 2026-08-04 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever mini softgels ACETAMINOPHEN 500 MG Shield Pharmaceuticals Corp 0ebb1902-6f8a-4bfb-9f2e-839d43bfca37 2026-08-04 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Better Living Brands, LLC 743af02c-c762-42f5-8e01-2f62da15e04e 2026-08-04 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC 9aea8aae-8702-4c93-8b07-69cd252f44d6 2026-08-03 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen 325 mg ACETAMINOPHEN NUVICARE LLC 49a59b79-b8b4-4bf5-a403-0a14751efc55 2026-08-03 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC d4e98f8e-f24c-4bdd-b750-fa4f877fb621 2026-07-31 Warnings Exact identifier application number: M013 KinderFarms Childrens Pain and Fever ACETAMINOPHEN KinderFarms, LLC 4f86419a-b940-a9c6-e063-6394a90a6a2b 2026-07-30 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Family Dollar Stores, LLC 53f7a9c8-f40e-19b2-e063-6394a90a8695 2026-07-29 Warnings Exact identifier application number: M013 KinderFarms Infants Pain and Fever ACETAMINOPHEN KinderFarms, LLC 5468b149-8fac-8d6a-e063-6294a90a8c51 2026-07-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS PHARMACY 258975d2-d8e8-407d-9804-df3b37a184e4 2026-07-29 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 3ba0a9f2-062a-401e-82eb-54383a822366 2026-07-29 Warnings Exact identifier application number: M013 Aspirin 81mg Enteric Coated ASPIRIN Cardinal Health 107, LLC 277723db-3578-4842-92eb-2de325f87649 2026-07-28 Warnings Exact identifier application number: M013 Aspirin Low Dose Chewable ASPIRIN Better Living Brands, LLC 7afce7b4-c86a-43f7-83cf-15ebffba2f35 2026-07-28 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC f818996c-36d2-4d3d-af3e-39949157edb9 2026-07-28 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L.N.K. International, Inc. 03b871e8-3e14-4ed8-a978-45129255b272 2026-07-27 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HCL Rite Aid Corporation 17d27771-a112-474f-9a58-29af0d7e1af3 2026-07-27 Warnings Exact identifier application number: M013 Infants TYLENOL ACETAMINOPHEN Kenvue Brands LLC 2143cc16-86db-4060-96da-5c228ae9207b 2026-07-24 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Softgel Healthcare Pvt Ltd 352bb451-ffdc-411a-e063-6294a90a8cf5 2026-07-24 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN NuCare Pharmaceuticals,Inc. fdb7331a-d029-8b2a-e053-6294a90adfcd 2026-07-24 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC 5ada044e-50e8-4874-ac04-df5f1f9e735d 2026-07-24 Warnings Exact identifier application number: M013
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 69168-319-86 69168031986 12 TABLET in 1 BLISTER PACK (69168-319-86) 12 tablet 2014-12-23 0000-00-00 No No Current