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 56 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Publix Fast Relief Effervescent ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Publix Super Markets Inc. 73051f16-2569-7394-e053-2991aa0a5359 2024-11-13 Warnings Exact identifier application number: M013 Quality Choice Effervescent Antacid and Pain Relief ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 70d265de-ff94-e0e4-e053-2a91aa0a962a 2024-11-13 Warnings Exact identifier application number: M013 Quality Choice Extra Strength Effervescent Antacid and Pain Relief ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 9f7d0c96-a561-a8a0-e053-2995a90a250b 2024-11-13 Warnings Exact identifier application number: M013 WinCo Foods Effervescent Antacid and Pain Relief ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET WinCo Foods, LLC 0c8a755a-089f-477f-97e9-0dd6fdfbe99d 2024-11-13 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Kroger Company 8fb19444-f0e0-4d26-81e8-6a4b835056d8 2024-11-12 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN WALMART INC. 59d01f72-4575-48e2-b914-b6a6456ca7d2 2024-11-11 Warnings Exact identifier application number: M013 pain and fever ACETAMINOPHEN Kroger Company d181560c-1c39-4f2e-8a17-996224ca040f 2024-11-09 Warnings Exact identifier application number: M013 Childrens Tylenol ACETAMINOPHEN Kenvue Brands LLC babcb210-6a47-46ef-b4ea-bdde80411cd3 2024-11-08 Warnings Exact identifier application number: M013 Bayer Genuine Aspirin ASPIRIN Acme United Corporation f7f9dc46-a945-7ae3-e053-6394a90a1192 2024-11-08 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC dd87e342-b0cb-4111-9f15-415dbcda4b77 2024-11-07 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 0c5fdda8-5049-46de-e063-6294a90a592b 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 46ddbfde-54ab-4373-b832-b9c0620b1e9d 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 333f6231-3778-4c1f-9558-2afddca22c86 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 34247a3b-0846-4086-becd-76e630b3b721 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC a51c2deb-c703-4dc8-9255-8ac9fe635170 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC ce0a1fbc-7345-462b-b0da-c7149bdc288c 2024-11-07 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC 015a6179-bacb-452d-b594-4de628ddc11d 2024-11-07 Warnings Exact identifier application number: M013 TYLENOL Regular Strength ACETAMINOPHEN Kenvue Brands LLC de5c6654-56c5-40d3-a286-f04ed47ac7c8 2024-11-07 Warnings Exact identifier application number: M013 Midol Complete ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE Acme United Corporation f7bf126d-a6f1-231a-e053-6294a90a04e1 2024-11-07 Warnings Exact identifier application number: M013 CareOne Childrens Acetaminophen ACETAMINOPHEN American Sales Company 49021ae8-9655-4885-9f74-52df4cdcb26f 2024-11-07 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