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 |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1086991 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3f020cf2-6011-4216-9b39-0b3dc5f0749c | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69168-319-86 | 2020-03-13 | C162847 | 48780-1 | 9d75b9d1-23e2-f424-e053-dadaa90a57ce | Drug Facts |
| 69168-319-86 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-23e2-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| 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#
DailyMed Dashboard NDC Coverage#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Good Neighbor Pharmacy Pain Relief | ACETAMINOPHEN | Amerisource Bergen | 5101125d-4819-4e4b-a0ee-a0ff8d5a0ab1 | 2024-10-30 | Warnings | M013 |
| Acetaminophen | PAIN RELIEVER | McKesson | 9d620700-5d00-475f-e053-2995a90a9a3f | 2024-10-28 | Warnings | M013 |
| Junior Acetaminophen Ages 6-11 | ACETAMINOPHEN | Chain Drug Consortium | d356bc9c-66f1-45c3-a455-98c0b8890f78 | 2024-10-28 | Warnings | M013 |
| leader Acetaminophen | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 36bdcac9-eed4-40f9-a6f2-4c1e773a6b50 | 2024-10-25 | Warnings | M013 |
| GOODYS PM | ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE | Medtech Products Inc. | db5d6c2b-688e-4e88-a42d-0fa2b0d8140b | 2024-10-25 | Warnings | M013 |
| Goodys Extra Strength | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Medtech Products Inc. | 16d774cc-4247-4bf8-9b5a-c338ffebda3d | 2024-10-25 | Warnings | M013 |
| aspirin | ASPIRIN | PUBLIX SUPER MARKETS INC | 9e77ab7a-07e8-42aa-e053-2995a90a0d0e | 2024-10-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Kroger Company | 5bfd9841-c781-43be-b823-d334893ae6ed | 2024-10-24 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | H E B | add6952e-9dd5-487c-93e6-337e9d6a4872 | 2024-10-24 | Warnings | M013 |
| Dye Free Pain Reliever Childrens | ACETAMINOPHEN | Safeway, Inc. | 7d55cb42-295f-473a-941d-71825b44a3c0 | 2024-10-24 | Warnings | M013 |
| rapid release pain relief | ACETAMINOPHEN | Publix Super Markets Inc | d0b34133-d69d-47db-bf51-be942769c612 | 2024-10-24 | Warnings | M013 |
| basic care acetaminophen | ACETAMINOPHEN | Amazon.com Services LLC | 00146b91-008d-4b16-95b0-6077f98821be | 2024-10-24 | Warnings | M013 |
| equate pain reliever | ACETAMINOPHEN | WALMART INC. | 9a20273e-a4d1-4c38-9efb-e6347f8dc14e | 2024-10-24 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | MARC GLASSMAN, INC. | e221905b-a795-c067-e053-2a95a90a02e7 | 2024-10-23 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | MARC GLASSMAN, INC. | e221bbce-83de-0f03-e053-2995a90abca5 | 2024-10-23 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | MARC GLASSMAN, INC. | e231c2f6-927c-1ab0-e053-2995a90a6121 | 2024-10-23 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | MARC GLASSMAN, INC. | e23703bb-6087-7985-e053-2995a90aa5ec | 2024-10-23 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | MARC GLASSMAN, INC. | e237550d-711d-5d87-e053-2995a90affce | 2024-10-23 | Warnings | M013 |
| Aspirin | ASPIRIN | HARRIS TEETER | a6f15f71-1327-4b71-b9d6-e3e9f0243801 | 2024-10-22 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | HARRIS TEETER | 43308b23-7d4f-4e4f-a497-af71920d86aa | 2024-10-22 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 3f020cf2-6011-4216-9b39-0b3dc5f0749c | 5 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 3f020cf2-6011-4216-9b39-0b3dc5f0749c | 5 |
| 1086991 | APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 3f020cf2-6011-4216-9b39-0b3dc5f0749c | 5 |
Packages#
| 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 |