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 |
|---|---|---|---|---|---|---|
| EXTRA STRENGTH PAIN RELIEVER | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Geri-Care Pharmaceutical Corp | b670a898-2360-76e2-e053-2a95a90a3380 | 2025-11-17 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | ec902e52-0f48-4a61-b67d-17e1c1461619 | 2025-11-15 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | L.N.K. International, Inc. | 72babe91-2586-4f05-ae90-6debfd23aa5d | 2025-11-15 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Strategic Sourcing Services LLC | 3c7883da-6f51-4716-b012-0e33d239a60e | 2025-11-15 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Sam's West Inc | 3b84746f-05ab-4f88-b9ae-efb8c5dfc233 | 2025-11-15 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Walgreen Company | a482e715-bec0-44a4-bb0e-ea5f5fda558e | 2025-11-15 | Warnings | M013 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | f1157dbc-d86c-4554-954c-60a74674ff6b | 2025-11-15 | Warnings | M013 |
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | NuCare Pharmaceuticals,Inc. | 437e4fd9-c7d9-77d6-e063-6294a90a22b7 | 2025-11-13 | Warnings | M013 |
| Good Sense Pain Relief | ACETAMINOPHEN | L. Perrigo Company | 7f78028a-484b-48b3-a37a-1e0b055bbefc | 2025-11-13 | Warnings | M013 |
| OneSsip Acetaminophen | ACETAMINOPHEN | MEDWISE LIFESCIENCES INC. | 3f88de0f-6cf6-3580-e063-6294a90abcb4 | 2025-11-12 | Warnings | M013 |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b1a31-353d-af20-e063-6294a90aa907 | 2025-11-11 | Warnings | M013 |
| Good Neighbor Pharmacy Pain Relief | ACETAMINOPHEN | Amerisource Bergen | 4b829607-f5fb-427f-83b5-5b6b9c44ebeb | 2025-11-11 | Warnings | M013 |
| Pamprin Max Menstrual Pain Relief | ACETAMINOPHEN AND ASPIRIN AND CAFFEINE | Focus Consumer Healthcare, LLC | 5bd4b935-f003-7df8-e053-2a91aa0a5d79 | 2025-11-10 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Shield Pharmaceuticals Corp | 61e50135-a7c2-4a86-8a1a-d47b41d3f9d1 | 2025-11-07 | Warnings | M013 |
| Childrens Chewables | ACETAMINOPHEN | Strategic Sourcing Services LLC | af2cbbaf-9b73-440a-bc88-a790cafccc6b | 2025-11-07 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | L.N.K. International, Inc. | 39e142a7-8590-4e1e-8319-6904fb57cc8a | 2025-11-06 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 42321456-d7dd-3b51-e063-6394a90ac292 | 2025-11-05 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | Family Dollar Services Inc | 76058eb3-2d3f-4414-87df-7167cd27d26b | 2025-11-05 | Warnings | M013 |
| Children Pain and Fever Reliver | ACETAMINOPHEN | Target Corporation | 1116f808-f61e-47ec-b0d0-d4be5aa905be | 2025-11-04 | Warnings | M013 |
| Pain Reliever Dye Free | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 42c4f0b2-6483-0f3c-e063-6294a90a140f | 2025-11-04 | 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 |