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 |
|---|---|---|---|---|---|---|
| Acetaminophen Diphenhydramine HCL | ACETAMINOPHEN DIPHENHYDRAMINE HCL | WALGREENS CO. | d92d97a8-0ee3-1206-e053-2a95a90a72a8 | 2025-12-19 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | SAM'S WEST INC | 0c8e7095-0806-4501-e063-6394a90a89aa | 2025-12-19 | Warnings | M013 |
| Acetaminophen Diphenhydramine HCL | ACETAMINOPHEN DIPHENHYDRAMINE HCL | WALGREEN CO. | b3763182-2428-155a-e053-2995a90ab578 | 2025-12-19 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | WALGREENS | e467b78e-9f23-5563-e053-2a95a90a586e | 2025-12-19 | Warnings | M013 |
| Acetaminophen Diphenhydramine HCL | ACETAMINOPHEN DIPHENHYDRAMINE HCL | Walgreens | fd7c3250-35d4-494a-e053-6394a90a2db5 | 2025-12-19 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | CVS PHARMACY, INC | 1ddb8a2b-3081-3eda-e063-6294a90ab82b | 2025-12-19 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | CVS PHARMACY, INC | b1307d52-10e6-46e1-e053-2995a90a03b6 | 2025-12-19 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | CVS PHARMACY, INC | c2c6d6a1-b492-506d-e053-2995a90aac23 | 2025-12-19 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | FAMILY DOLLAR | f8383108-0970-9f1e-e053-6294a90ad38f | 2025-12-19 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | NUVICARE LLC | 591ee107-e953-4982-b75f-13a0afd7c4ae | 2025-12-19 | Warnings | M013 |
| Nuvicare Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | NUVICARE LLC | 3ede0fb6-c089-4253-9878-2b01c39e9c87 | 2025-12-19 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | NUVICARE LLC | 3a4aa3c7-b726-4303-8803-74196fa5637a | 2025-12-19 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | NUVICARE LLC | 95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e | 2025-12-19 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE | NUVICARE LLC | 32a5611b-9bf6-4850-a7ff-fa240da04f45 | 2025-12-19 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | BETTER LIVING BRANDS LLC. | ac0e96d0-746e-fb42-e053-2a95a90a1957 | 2025-12-18 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | BETTER LIVING BRANDS LLC. | ac0e5dc0-96eb-47b2-e053-2995a90add0e | 2025-12-18 | Warnings | M013 |
| Acetaminophen Diphenhydramine HCl | ACETAMINOPHEN DIPHENHYDRAMINE HCL | BETTER LIVING BRANDS LLC. | ac0f8d5c-d200-1156-e053-2a95a90aece6 | 2025-12-18 | Warnings | M013 |
| Pain and Fever Childrens | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | e55645ab-66f9-4160-8247-395bc5b02711 | 2025-12-18 | Warnings | M013 |
| Dolex Forte | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Pharmadel LLC | 3c2d90fc-130d-476c-e063-6294a90a8c15 | 2025-12-17 | Warnings | M013 |
| CareOne Childrens Acetaminophen | ACETAMINOPHEN | American Sales Company | 07bc6632-fabb-427d-81f3-c27c54caa6a0 | 2025-12-17 | 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 |