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 |
|---|---|---|---|---|---|---|
| good sense pain relief | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 3c1f505d-0319-a179-e063-6294a90a0b17 | 2025-08-11 | Warnings | M013 |
| Aspirin | ASPIRIN | PROSTAT FIRST AID | 3bdb9d89-9000-69f9-e063-6294a90a0c97 | 2025-08-08 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Prostat First Aid | 3bdbea6a-3f11-9142-e063-6294a90a20ea | 2025-08-08 | Warnings | M013 |
| Aspi-Cor | ASPIRIN | L.N.K. International, Inc. | 9f919a48-ffd8-49fa-b6fd-ec71cc12e64b | 2025-08-08 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | A-S Medication Solutions | 8575ef9d-2eae-412a-a252-82b03f4d5275 | 2025-08-08 | Warnings | M013 |
| Aspirin | ASPIRIN | A-S Medication Solutions | 7a91b1df-8d6d-4205-9822-bc4d800555f7 | 2025-08-08 | Warnings | M013 |
| M-PAP | ACETAMINOPHEN | Bryant Ranch Prepack | 3d6bf733-800c-420a-a9ab-ae4a26134799 | 2025-08-08 | Warnings | M013 |
| Aspirin | ASPIRIN | A-S Medication Solutions | 44b8c203-37c5-425e-9110-f7eb614f9c2d | 2025-08-08 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION INC | c46688ec-e976-4f76-9265-645f59970ff5 | 2025-08-06 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | P & L Development, LLC | c54ad829-f2e8-4367-b439-af20b0ef8ad2 | 2025-08-06 | Warnings | M013 |
| TYLENOL Regular Strength | ACETAMINOPHEN | Kenvue Brands LLC | 398d8996-b522-a3cd-e063-6394a90ac2c8 | 2025-08-06 | Warnings | M013 |
| Aspirin | ASPIRIN | Marlex Pharmaceuticals Inc. | cc7013ea-cf30-6f59-e053-2a95a90a1148 | 2025-08-05 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Prostat First Aid | 3ba313db-bafe-1947-e063-6294a90a528c | 2025-08-05 | Warnings | M013 |
| MEDIQUE APAP acetaminophen | MEDIQUE APAP ACETAMINOPHEN | HF Acquisition Co LLC, DBA HealthFirst | 3ba5c802-fe5a-e42a-e063-6394a90ae67e | 2025-08-05 | Warnings | M013 |
| meijer EXTRA STRENGTH Pain Relief PM CAPLET | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 376fed3b-7625-6379-e063-6394a90a188d | 2025-08-05 | Warnings | M013 |
| CAREONE INFANTS ACETAMINOPHEN | ACETAMINOPHEN | Retail Business Services, LLC | b8024ec2-97c6-4aa1-b1dd-894164f48811 | 2025-08-04 | Warnings | M013 |
| Exaprin Plus | ASPIRIN, ACETAMINOPHEN, CAFFEINE | HART Health | 8a9ca680-e6cf-4ee4-8a5f-bd6d7470b848 | 2025-08-04 | Warnings | M013 |
| Aspirin | ASPIRIN | Proficient Rx LP | 2ef0757a-fe5f-47de-906a-a4d47a0d0534 | 2025-08-01 | Warnings | M013 |
| Good Sense Pain Relief | ACETAMINOPHEN | Proficient Rx LP | b4cb4a62-9ef7-4185-8770-e9a806c2fb3f | 2025-08-01 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | AAA Pharmaceutical, Inc. | 36ad21a3-6229-e91b-e063-6394a90a7933 | 2025-07-29 | 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 |