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 |
|---|---|---|---|---|---|---|
| Chewable Aspirin | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | c94d68ea-7f25-881f-e053-2995a90aa47f | 2024-10-15 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | c94d750e-5a85-77f5-e053-2995a90a6915 | 2024-10-15 | Warnings | M013 |
| Infants Pain and Fever | ACETAMINOPHEN | Walgreen Company | 9e08eb38-7538-4fa0-a0e1-047ab6cb1680 | 2024-10-15 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | PUBLIX SUPER MARKETS INC | 9e779cc6-4641-6132-e053-2a95a90a3493 | 2024-10-11 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | CHAIN DRUG CONSORTIUM | 5c1a3081-ae25-4895-bf76-ebcbb9fc8072 | 2024-10-11 | Warnings | M013 |
| Aspirin 81 MG | ASPIRIN | Meijer | b3e5711c-9529-4eec-871d-de8efa858b86 | 2024-10-11 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | MEIJER DISTRIBUTION INC | 9586e830-a285-4a07-8b34-969875442348 | 2024-10-11 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | Chain Drug Marketing Association | 68a52858-35c5-402a-8ceb-8d8a7c1e5f6c | 2024-10-11 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | Chain Drug Marketing Association | 5de40821-3218-4320-bf11-9493bf01d489 | 2024-10-11 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 475becec-1a56-4cfa-a0c5-562f8772adfb | 2024-10-11 | Warnings | M013 |
| Topcare Pain Relief | ACETAMINOPHEN | Topco Associates LLC | 6036c15b-1168-4103-9471-6a74a2140e53 | 2024-10-10 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | 46d9d8cd-e3db-492c-9386-7e8255beff64 | 2024-10-08 | Warnings | M013 |
| dg health aspirin | ASPIRIN | Dolgencorp, LLC | 0ab34dc7-0110-4fc3-ae53-234e7d7bca3c | 2024-10-07 | Warnings | M013 |
| ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | 19ba1fb6-22ea-488e-9e52-94c14ceb80d1 | 2024-10-07 | Warnings | M013 |
| foster and thrive aspirin | ASPIRIN | Strategic Sourcing Services LLC | 4d66a8a8-a1c1-4430-8845-21ae67700c39 | 2024-10-07 | Warnings | M013 |
| leader aspirin | ASPIRIN | Cardinal Health 110, LLC. dba Leader | ca603b12-e0f7-4d79-8e0d-4651a788ba9b | 2024-10-07 | Warnings | M013 |
| foster and thrive aspirin | ASPIRIN | McKesson Medical-Surgical, Inc. | e9342478-93d6-45de-948f-f4162ee675b2 | 2024-10-07 | Warnings | M013 |
| Maximum Strength Backache Relief | MAGNESIUM SALICYLATE | JHK DBA American Safety & First Aid | f8cbcd4e-cfad-4592-8774-52e681494c45 | 2024-10-07 | Warnings | M013 |
| Alka-Seltzer Original Flavor | ALKA-SELTZER ORIGINAL FLAVOR | Navajo Manufacturing Company Inc. | f70875ab-241c-4876-e053-6294a90a8092 | 2024-10-03 | Warnings | M013 |
| Tylenol Extra Strength | ACETAMINOPHEN | Navajo Manufacturing Company Inc. | 86b6ac01-3866-4cd8-a1be-9babb6ff311b | 2024-10-02 | 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 |