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 |
|---|---|---|---|---|---|---|
| MAXIMUM STRENGTH NON-ASPIRIN 100 | ACETAMINOPHEN | JHK Inc dba American Safety & First Aid | 1d3e9948-883e-4668-9bb8-d699a283b51a | 2025-12-16 | Warnings | M013 |
| TYLENOL EXTRA STRENGTH, TRAVEL BASIX | ACETAMINOPHEN | Lil' Drug Store Products, Inc. | fa951d50-b79c-4161-8c81-fcf386b0964e | 2025-12-15 | Warnings | M013 |
| Vanquish Extra Strength | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | DSE Healthcare Solutions, LLC | cbf12223-ef44-494b-9d3c-971dce3c5ade | 2025-12-15 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 8bc75bcf-01c9-41d0-a96f-77a24e3edf01 | 2025-12-15 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALGREENS | 40a1b354-9b2e-1cf3-e063-6394a90af113 | 2025-12-13 | Warnings | M013 |
| topcare childrens pain and fever | ACETAMINOPHEN | Topco Associates LLC | 911492d5-e065-4b8f-b2dc-cb6a6678d0ae | 2025-12-13 | Warnings | M013 |
| Pain Reliever, Extra Strength, 24-7 Life by 7-Eleven | ACETAMINOPHEN TABLET | Lil' Drug Store Products, Inc. | 45c397bd-a1ff-1246-e063-6394a90ac54a | 2025-12-12 | Warnings | M013 |
| Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 45c7c11b-d627-aee8-e063-6294a90a401d | 2025-12-12 | Warnings | M013 |
| Aspirin | ASPIRIN | TOP CARE (Topco Associates LLC) | d3df90be-9037-44b2-bf48-540d68a033b2 | 2025-12-12 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Hy-Vee | 98ab6fb7-c7e5-45ab-97c3-81d422f8a843 | 2025-12-11 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | 33599f18-5f49-4f22-8a77-a072115763ef | 2025-12-11 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | VALU MERCHANDISERS COMPANY | 746059b3-ed18-4a81-a70e-4d758e048d8e | 2025-12-11 | Warnings | M013 |
| Extra Strength Pain Relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | f8820150-feec-4062-85bb-14525ddf691f | 2025-12-11 | Warnings | M013 |
| Extra Strength Pain Relief | ACETAMINOPHEN | VALU MERCHANDISERS COMPANY | 005e299e-aa84-49d9-bbca-12236f865a27 | 2025-12-11 | Warnings | M013 |
| Low Dose Chewable Aspirin | ASPIRIN | VALU MERCHANDISERS COMPANY | 7d88f156-d361-4249-b70d-4bbcd5ba30b7 | 2025-12-11 | Warnings | M013 |
| Enteric Coated Aspirin | ASPIRIN | VALU MERCHANDISERS COMPANY | cc18e8e1-652e-44da-a9d7-e56cebda55a1 | 2025-12-11 | Warnings | M013 |
| Extra Strength Pain Relief | ACETAMINOPHEN | VALU MERCHANDISERS COMPANY | d4c32e70-778a-4d66-b9d0-03944a528421 | 2025-12-11 | Warnings | M013 |
| adult low dose aspirin | ASPIRIN | VALU MERCHANDISERS COMPANY | 6fa1c707-bd42-455b-90a3-2c2a11acc683 | 2025-12-11 | Warnings | M013 |
| Extra Strength Pain Relief | ACETAMINOPHEN | VALU MERCHANDISERS COMPANY | 5a80cb17-7731-4457-acd3-64cf4accf862 | 2025-12-11 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | VALU MERCHANDISERS COMPANY | 02e3798f-86d9-64b4-e063-6294a90a29de | 2025-12-11 | 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 |