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 |
|---|---|---|---|---|---|---|
| TEXACLEAR PAIN RELIEVER | CAFFEINE, CHOLINE SALICYLATE | GM Pharmaceuticals, INC | 065bd10c-3bcf-486f-a49c-40544127007f | 2025-10-15 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | ASCLEMED USA INC. | db8e6702-88ac-4db2-9dd8-7d0ed997c2b5 | 2025-10-14 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Walgreen Company | fa33f6ef-522b-4630-9716-92371d9cd24a | 2025-10-14 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | Rite Aid Corporation | a8bb4f45-7a1a-4bf7-92ca-3afd508032f3 | 2025-10-09 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Health Pharma USA LLC | b15a7dcb-f143-4aea-8850-d0aacbf709b6 | 2025-10-09 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PD-Rx Pharmaceuticals, Inc. | 3f96aeb1-a533-4d36-9a1f-62fc094b6754 | 2025-10-08 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Walgreens | f2eb9575-d527-44c7-aa5e-efabfd9a0278 | 2025-10-07 | Warnings | M013 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | bbc704e5-79f6-4c72-846b-cc30c5c43cb4 | 2025-10-07 | Warnings | M013 |
| Aspirin Enteric Coated | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION INC | f1ce15a3-9824-4eb5-910a-39078165f385 | 2025-10-07 | Warnings | M013 |
| BupropiDex | DEXTROMETHORPHAN HYDROBROMIDE | DXM Pharmacuetical, Inc. | 90cc9bcd-7891-4324-a1f4-f6df7a0457e0 | 2025-10-06 | Warnings | M013 |
| Dextabs | DEXTROMETHORPHAN HYDROBROMIDE | DXM Pharmacuetical, Inc. | 71b567df-844a-4563-b85a-f4592233f37d | 2025-10-06 | Warnings | M013 |
| Acetaminophen, Aspirin and Caffeine | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Rising Pharma Holdings, Inc. | 50f72713-50f5-4bab-9e96-b9fa73c9df1f | 2025-10-06 | Warnings | M013 |
| OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mL | ACETAMINOPHEN 160 MG / 5 ML | MEDWISE LIFESCIENCES INC. | 40507559-aee4-a603-e063-6394a90afc4f | 2025-10-04 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 004c39cd-b4f4-1cae-e063-6394a90a0697 | 2025-10-03 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Family Dollar (FAMILY WELLNESS) | 43573e35-6776-446e-aa28-75c8edc5b98d | 2025-10-03 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Family Dollar (FAMILY WELLNESS) | f8e5fab4-1212-4c60-a160-9b782f76a198 | 2025-10-03 | Warnings | M013 |
| CVS Acetaminophen | ACETAMINOPHEN | CVS Pharmacy | 3d71a0aa-5e03-0bdc-e063-6294a90a6634 | 2025-10-02 | Warnings | M013 |
| Chewable Aspirin | ASPIRIN | Chain Drug Marketing Association, Inc. | cc865351-34e8-4e8e-b8bf-23336c45bc61 | 2025-10-02 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Bryant Ranch Prepack | 8e40f8f1-03c5-444b-8b5e-4532c3146e47 | 2025-10-02 | Warnings | M013 |
| ASPIRIN 325 MG EC | ASPIRIN | Proficient Rx LP | 9f9355f7-024a-4adc-bb4c-2d9c0dd0cb77 | 2025-10-01 | 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 |