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 |
|---|---|---|---|---|---|---|
| Aspirin 81 mg Low Dose | ASPIRIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 23b29044-6389-42ea-839a-5351557a6ce3 | 2026-04-23 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4a70867e-481d-4f01-9da3-d85663a1672e | 2026-04-23 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | United Natural Foods, Inc. dba UNFI | 07edcb31-d31d-4607-98c3-dcb1e062cc70 | 2026-04-22 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | ee50c5ee-1a61-4efc-aca9-42d897d6a3b8 | 2026-04-22 | Warnings | M013 |
| Aspirin | ASPIRIN | CVS PHARMACY | 904a2b21-d911-40c3-9e4b-59543ea5be4f | 2026-04-22 | Warnings | M013 |
| Pamprin Multi-Symptom Maximum Strength | ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE | Focus Consumer Healthcare, LLC | 60b3286d-5698-df50-e053-2991aa0afbe2 | 2026-04-20 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | CVS PHARMACY | af6fe4a9-2d18-4fed-b952-0a7866f65251 | 2026-04-20 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | Preferred Pharmaceuticals Inc. | ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e | 2026-04-20 | Warnings | M013 |
| Parry-500mg Acetaminophen | ACETAMINOPHEN | MDC PHARMACEUTICALS LIMITED | fb07ba10-3210-41bc-9310-c952118fdcf3 | 2026-04-17 | Warnings | M013 |
| Aspirin NSAID | ASPIRIN | Valu Merchandisers Company | 0cc46a81-54c9-44b7-b384-79d25255eff2 | 2026-04-17 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Valu Merchandisers Company | 99de2c41-59b0-42e7-847e-e51229c6164f | 2026-04-17 | Warnings | M013 |
| Pain and Fever Childrens | ACETAMINOPHEN | Walgreen Company | 1f3e2895-5ef7-4e6a-8d2e-b805d148f980 | 2026-04-16 | Warnings | M013 |
| Childrens TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | b297aff8-a08b-4d37-b168-800a56564cbd | 2026-04-16 | Warnings | M013 |
| Childrens Tylenol | ACETAMINOPHEN | Kenvue Brands LLC | 9782fe86-d72a-4231-b1ba-d3f3b4ee49e3 | 2026-04-16 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | 8e65478b-7a7b-416c-b8e3-23dad79f8cc1 | 2026-04-16 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Valu Merchandisers Company | c9e384e5-fa9b-4c75-b5e3-16eb8db662ef | 2026-04-16 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | b6abfbbb-9826-4cd6-940f-3a314480a5a5 | 2026-04-15 | Warnings | M013 |
| Good Sense Pain and Fever | ACETAMINOPHEN | L. Perrigo Company | f7137fe6-582e-43a4-8302-90ca54cd1de3 | 2026-04-14 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | e13656eb-513e-411e-bdae-35ff1ba7cfc1 | 2026-04-13 | Warnings | M013 |
| CareOne Acetaminophen | ACETAMINOPHEN | American Sales Company | b4f54465-3232-4685-9570-90be00876577 | 2026-04-12 | 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 |