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 |
|---|---|---|---|---|---|---|
| Childrens Mapap | ACETAMINOPHEN | Major Pharmaceuticals | efec6af2-8b26-47f6-88c8-b0a6d69a2d7d | 2026-06-03 | Warnings | M013 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | ae3114c3-8cfe-4b81-8ac7-c281fe68b462 | 2026-06-03 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | COSTCO WHOLESALE CORPORATION | 3745aa18-a711-43ed-9bc4-1f087b3c53c0 | 2026-06-03 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 3f653262-b931-7d42-e063-6394a90adddd | 2026-06-03 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Walgreen Company | 0b1bef50-7957-4ea1-9ae3-91f59ea2dbb4 | 2026-06-03 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALMART INC. | 42310898-cf3a-4ffb-88bb-b8b84449156e | 2026-06-02 | Warnings | M013 |
| PAIN RELIEF | ACETAMINOPHEN | Meijer, Inc. | 1319bab8-8f17-44fb-9d91-099b0ba38a8d | 2026-06-01 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Family Dollar (FAMILY WELLNESS) | 7a98d4d9-54e2-45c1-a76a-7f1907566e95 | 2026-06-01 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 58840cf4-aceb-c7cf-e063-6294a90a5ff4 | 2026-06-01 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS Pharmacy | 832acd72-1dda-4490-978f-5f31748942df | 2026-06-01 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 786dbcd5-f5c2-4491-e053-2991aa0a3437 | 2026-05-29 | Warnings | M013 |
| Back and Body Extra Strength | ASPIRIN, CAFFEINE | Meijer Distribution Inc | e513f2d9-d591-4790-a117-6176ce2279dc | 2026-05-29 | Warnings | M013 |
| Chewable Acetaminophen Childrens | ACETAMINOPHEN | Cardinal Health 110, LLC. DBA Leader | 5460a4b7-5da3-4fc2-a565-0b0dd11bbf44 | 2026-05-29 | Warnings | M013 |
| Extra Strength Mini Softgels Pain Reliever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | f55d3663-7007-41cd-ae2d-5aca6311be81 | 2026-05-28 | Warnings | M013 |
| Genexa Kids Pain and Fever | ACETAMINOPHEN | Genexa Inc. | 5130c695-a80e-2dd3-e063-6294a90a404f | 2026-05-28 | Warnings | M013 |
| TYLENOL Regular Strength | ACETAMINOPHEN | Kenvue Brands LLC | 1622f694-4d63-4c56-8737-fae31f0ecfb7 | 2026-05-27 | Warnings | M013 |
| INFANTS Pain and Fever | ACETAMINOPHEN | Aurohealth LLC | 257436e1-e0f3-4a87-bffe-4f176b836caf | 2026-05-27 | Warnings | M013 |
| Infants Pain and Fever | ACETAMINOPHEN | Aurohealth LLC | 6509a545-0036-460a-8f0d-b31caae17855 | 2026-05-27 | Warnings | M013 |
| Alka-Seltzer Original | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | Select Consumer Group | 3ca80d74-1e8b-49d9-e063-6394a90a4312 | 2026-05-24 | Warnings | M013 |
| Pain and Fever Chewables Childrens | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | bad8ac0a-518d-4639-9b92-a39e0d437238 | 2026-05-22 | 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 |