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 |
|---|---|---|---|---|---|---|
| Excedrin Extra Strength Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE | Select Consumer Group | 3caa0a47-de83-90d2-e063-6394a90a3436 | 2025-12-27 | Warnings | M013 |
| Aspirin Pain reliver | ASPIRIN | Pioneer Life Sciences, LLC | c2759844-a49c-450f-e053-2a95a90a2972 | 2025-12-26 | Warnings | M013 |
| Menstrual Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | Pioneer Life Sciences, LLC | aa2de3a5-a20d-33c6-e053-2a95a90ada3e | 2025-12-26 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Discount Drug Mart | 2aa0f9f3-924c-4a4a-bb5f-2a326acc2408 | 2025-12-26 | Warnings | M013 |
| GenCare Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Pioneer Life Sciences, LLC | 667f6f1b-5179-481c-a131-940c7937aada | 2025-12-26 | Warnings | M013 |
| Pharbetol | ACETAMINOPHEN | Pharbest Pharmaceuticals, Inc. | 04dbd98f-c74d-43b2-8bda-74f18be7cf6c | 2025-12-24 | Warnings | M013 |
| Adult Low Dose Aspirin Enteric Coated | ASPIRIN 81MG | Pharbest Pharmaceuticals, Inc. | 45e5bae9-22a7-4699-85ea-5b922af6b96d | 2025-12-24 | Warnings | M013 |
| Aspirin 325 mg | ASPIRIN | BETTER LIVING BRANDS, LLC | 424a242f-c8c6-9dd7-e063-6394a90ab4d5 | 2025-12-24 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Pharbest Pharmaceuticals, Inc. | 2763a733-d617-4d95-8429-fbf81d9d77fb | 2025-12-24 | Warnings | M013 |
| Pharbetol Regular strength | ACETAMINOPHEN | Pharbest Pharmaceuticals, Inc. | e0a39957-d918-4125-88f9-0e550b976fa1 | 2025-12-24 | Warnings | M013 |
| PHARBETOL | ACETAMINOPHEN 500MG | Pharbest Pharmaceuticals, Inc. | 27337be9-e279-460e-903e-ae4463099599 | 2025-12-24 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PUBLIX SUPERMARKETS, INC | 08f5af1d-365b-a97c-e063-6394a90a99ae | 2025-12-23 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | Pioneer Life Sciences, LLC | 0d67bb52-7ae3-439e-9e47-4e21eb0ca352 | 2025-12-23 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | Pioneer Life Sciences, LLC | 11e6ec2a-5171-4496-a15f-6ff744bd1f2f | 2025-12-23 | Warnings | M013 |
| Aspirin Pain reliver | ASPIRIN | Pioneer Life Sciences, LLC | 8dc29957-2ac1-47f8-89fd-a6bcf97ee3d3 | 2025-12-23 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Granules USA, Inc | a1255f60-b9c6-9a95-e053-2995a90a9e80 | 2025-12-22 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Granules USA, Inc | a51395ea-e038-dc9c-e053-2a95a90a287d | 2025-12-22 | Warnings | M013 |
| CareALL Acetaminophen | ACETAMINOPHEN | New World Imports, Inc | 1148b4d9-fa6a-49e6-9663-17b2c8373846 | 2025-12-22 | Warnings | M013 |
| CAREALL Aspirin | ASPIRIN | New World Imports, Inc | f4aa0de9-ffcc-4140-91a3-fd9e7a55f2ac | 2025-12-22 | Warnings | M013 |
| Vitapirena | ACETAMINOPHEN | Pharmadel LLC | 0547bc1f-d000-f5a6-e063-6294a90ac73d | 2025-12-22 | 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 |