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 6 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join childrens fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation a63727c3-64d8-4ae9-8da3-974cae6beed2 2026-07-24 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Aurohealth LLC e4a2566e-48ec-4602-87e3-143398d15f33 2026-07-24 Warnings Exact identifier application number: M013 infants fever reducer and pain reliever ACETAMINOPHEN Rite Aid Corporation 920e7055-7ed1-4db4-9215-f8933078bb7b 2026-07-24 Warnings Exact identifier application number: M013 Dye Free Pain and Fever Childrens ACETAMINOPHEN Walgreens c6665c11-9a01-4472-a444-acadb1de0b69 2026-07-23 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 103d109d-f520-409c-8da2-eb6b0fbec891 2026-07-22 Warnings Exact identifier application number: M013 Tylenol PM Extra Strength ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Kenvue Brands LLC ce58105b-f010-47af-8f31-6dd4ce4e9cba 2026-07-22 Warnings Exact identifier application number: M013 GOOD SENSE INFANTS PAIN AND FEVER ACETAMINOPHEN L. Perrigo Company a7cc3964-e8fa-41da-89ca-b0d2aa80f2a7 2026-07-22 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Cardinal Health 107, LLC 7562f4e4-54fa-488c-a199-48ad2632e2a1 2026-07-21 Warnings Exact identifier application number: M013 Medline ACETAMINOPHEN Medline Industries, LP 4b1d7243-b943-4e2b-e063-6294a90a2c4e 2026-07-20 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN LEADER/ Cardinal Health 110, Inc. 7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d 2026-07-16 Warnings Exact identifier application number: M013 Rapidol 500 Extra Strength ACETAMINOPHEN Pharmadel LLC 1d9fa7ec-a509-28b2-e063-6294a90a7831 2026-07-16 Warnings Exact identifier application number: M013 equate pain relief ACETAMINOPHEN WALMART INC. 2f9b2550-5476-49ae-b741-54416a40bc29 2026-07-16 Warnings Exact identifier application number: M013 Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL HyVee Inc 4f45a750-1220-4a81-801e-bf08c9d117d6 2026-07-16 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Dr. Reddy's Laboratories Inc. 9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f 2026-07-15 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Family Dollar, Inc. 3f182571-3212-eb29-e063-6294a90a9fa0 2026-07-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN DOLGENCORP, LLC 955484a6-2a7a-4b15-a9b4-e888ed5de04c 2026-07-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Geri-Care Pharmaceuticals, Corp 58941782-362d-4436-b365-e909bdbd29a2 2026-07-15 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Major Pharmaceuticals 44730dfb-5062-4015-924b-c30b6c2b19c2 2026-07-13 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Cardinal Health 110, LLC. DBA Leader f1cd0d59-12a8-4ff2-942a-6faa6907ef05 2026-07-13 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Amerisource Bergen 2c5e80e8-a979-45fb-9297-8ff294280c25 2026-07-13 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