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 |
|---|---|---|---|---|---|---|
| Low Dose Aspiriun | ASPIRIN | AMERIFOODS TRADING COMPANY | 3802c96a-5e2a-ba9c-e063-6394a90abb78 | 2025-11-20 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 4227aeb1-dd2c-9ca1-e063-6294a90ad709 | 2025-11-20 | Warnings | M013 |
| good sense pain relief | ACETAMINOPHEN | NuCare Pharamceuticals, Inc. | 440c13d7-edf0-f611-e063-6394a90af995 | 2025-11-20 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 4227a2cc-69fa-869d-e063-6294a90a1d41 | 2025-11-20 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 422796ed-7558-f7e8-e063-6294a90ad1c7 | 2025-11-20 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 3e61abe4-b4be-01af-e063-6394a90a8b24 | 2025-11-20 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 3e60703b-a5cf-333a-e063-6394a90a2087 | 2025-11-20 | Warnings | M013 |
| ASPIRIN | ASPIRIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 54e4ae54-caf8-4105-8428-256f56a2f68f | 2025-11-19 | Warnings | M013 |
| MIDOL COMPLETE | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | R J General Corporation | 0c09a178-1a07-4079-b4a6-d1657cb8e714 | 2025-11-17 | Warnings | M013 |
| Alka-Seltzer Original | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | R J General Corporation | dbb0d067-71f0-45e4-bc98-548cf4a90b3a | 2025-11-17 | Warnings | M013 |
| MOTRIN IB | IBUPROFEN | R J General Corporation | afa87bb5-7fcb-4ccd-acac-f7931242181f | 2025-11-17 | Warnings | M013 |
| TYLENOL EXTRA STRENGTH | ACETAMINOPHEN | R J General Corporation | 99e45e83-37a3-44df-9a2a-98ba7457a5bb | 2025-11-17 | Warnings | M013 |
| TYLENOL PM EXTRA STRENGTH | ACETAMINOPHEN | R J General Corporation | a40ea0e3-d666-4605-b5e0-beeaf8f586f2 | 2025-11-17 | Warnings | M013 |
| Acetaminophen 250 mg and Ibuprofen 125 mg | ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG | R J General Corporation | 68d3be55-9340-4cc9-a05a-12b9338ddc56 | 2025-11-17 | Warnings | M013 |
| Ibuprofen 200 mg | IBUPROFEN | R J General Corporation | dd9aaf80-6c2b-41a3-87b9-61642aaed4f0 | 2025-11-17 | Warnings | M013 |
| Ibuprofen 200 mg | IBUPROFEN | R J General Corporation | 1c18a2da-1718-4c00-aea8-9fb4a3418312 | 2025-11-17 | Warnings | M013 |
| Ibuprofen 200 mg | IBUPROFEN | R J General Corporation | cd3060a5-3b90-42e4-89cd-3b620859045f | 2025-11-17 | Warnings | M013 |
| Ibuprofen 200 mg | IBUPROFEN | R J General Corporation | 1c7221ae-52d1-4d18-b586-c47ff656150d | 2025-11-17 | Warnings | M013 |
| Excedrin Extra Strength Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE | R J General Corporation | 907c89e7-2482-465f-9f85-2381ecab1b86 | 2025-11-17 | Warnings | M013 |
| Bayer Genuine Aspirin | ASPIRIN | R J General Corporation | 23daa359-d40f-4f64-81be-6d154f41df9f | 2025-11-17 | 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 |