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 |
|---|---|---|---|---|---|---|
| Menstrual Relief Maximum Strength | ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE | United Natural Foods, Inc. dba UNFI | 807598ef-9f03-48df-b076-3ee95ef4b06c | 2026-01-05 | Warnings | M013 |
| Pain Relief Extra Strength, Non-Aspirin | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | 1fb5e871-45fd-46fe-bf73-5192f8316e8e | 2026-01-02 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Valu Merchandisers Company | 0005aafa-08f8-4990-a54d-cc097195708f | 2026-01-02 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN | Walmart Inc. | 152bb455-da5b-ae13-e063-6394a90acab0 | 2026-01-01 | Warnings | M013 |
| Dr. Cocoa for Children Pain and Fever | ACETAMINOPHEN | Infirst Healthcare Inc. | 486ea294-6d18-a907-e063-6294a90ad284 | 2026-01-01 | Warnings | M013 |
| ED APAP | ACETAMINOPHEN | EDWARDS PHARMACEUTICALS, INC. | f76d5fff-ebea-40f9-aad3-4064a0c863f0 | 2025-12-31 | Warnings | M013 |
| EXTRA STRENGTH PAIN RELIEF | ACETAMINOPHEN | GERI-CARE PHARMACEUTICAL CORP | 99ec63ef-aa28-c2fb-e053-2a95a90a9f6d | 2025-12-31 | Warnings | M013 |
| Puregen Labs Acetaminophen | ACETAMINOPHEN | Advanced Rx LLC | 474580af-f6b0-e440-e063-6394a90aaada | 2025-12-31 | Warnings | M013 |
| Liquid Acetaminophen | ACETAMINOPHEN | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | a7dbd4c0-53eb-4368-917b-1432c09ce6b4 | 2025-12-31 | Warnings | M013 |
| Llorens Care Children Acetaminophen | ACETAMINOPHEN | Llorens Pharmaceutical International Division, Inc. | 2a46d7d2-293b-5024-e063-6294a90a31aa | 2025-12-31 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE) | Walgreens | 3a801457-c5d0-b134-e063-6294a90ac5cb | 2025-12-31 | Warnings | M013 |
| Daytime and Nighttime Severe Cold and Flu combo pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Genexa Inc. | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2025-12-30 | Warnings | M013 |
| BioElectro Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Genomma Lab USA | 683a0fba-921c-48e7-a391-180c04f0d1c4 | 2025-12-30 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE | Pioneer Life Sciences, LLC | 0181af13-da32-4431-be39-c31fdfac9202 | 2025-12-29 | Warnings | M013 |
| Gemma Cut the Cramp | ASPIRIN, CAFFEINE | Rally Labs LLC | 16c9a296-077a-8e12-e063-6294a90a1b8b | 2025-12-29 | Warnings | M013 |
| Blowfish | ASPIRIN, CAFFEINE | Rally Labs LLC | 0d3798bc-04ef-584e-821b-7aa76036b7d1 | 2025-12-29 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE | Pioneer Life Sciences, LLC | ad29a37f-39a2-5c84-e053-2995a90a2f39 | 2025-12-29 | Warnings | M013 |
| Tension Headache Relief | ACETAMINOPHEN, CAFFEINE | Pioneer Life Sciences, LLC | ac9efd62-8fee-b777-e053-2995a90a3783 | 2025-12-29 | Warnings | M013 |
| Childrens Pain Relief and Fever Reducer Oral Suspension Cherry | ACETAMINOPHEN | Puro Pharma Inc. | a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009 | 2025-12-27 | Warnings | M013 |
| Cystex PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Clarion Brands, LLC | 9668a2ca-729e-4172-80b5-33e6c5175ba4 | 2025-12-27 | 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 |