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 Low Dose | ASPIRIN | ATLANTIC BIOLOGICALS CORP. | 024c5054-959f-4ea5-a71f-c0e16cc4b90c | 2025-06-24 | Warnings | M013 |
| CHILDRENS ACETAMINOPHEN | CHILDRENS ACETAMINOPHEN ORAL | AARNA USA INC. | 38070d15-2678-4e59-e063-6294a90ab690 | 2025-06-20 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Morning Star OTC | 8502ea21-937d-4b33-a3e0-ffab5dc38cd8 | 2025-06-19 | Warnings | M013 |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Morning Star OTC | 6cd07a01-7034-4994-bbd3-bedcdf7d5b83 | 2025-06-19 | Warnings | M013 |
| DRX CHOICE Tension Headache | ACETAMINOPHEN, CAFFEINE | Raritan Pharmaceuticals Inc. | 8a5cb38b-669d-4177-b33b-d73c7ef48d18 | 2025-06-13 | Warnings | M013 |
| good sense childrens pain and fever | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 3777f4fb-d279-199d-e063-6394a90acf36 | 2025-06-13 | Warnings | M013 |
| Aspirina Cafeina | ASPIRIN,CAFFEINE | Bayer HealthCare LLC. | 2e709acc-325a-baca-e063-6394a90a24be | 2025-06-12 | Warnings | M013 |
| Aspirin | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 696f55b1-536c-40c4-91f7-b572c39220db | 2025-06-11 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | CVS Pharmacy, Inc. | 6dea9e11-ff99-63c7-e053-2a91aa0a5b54 | 2025-06-10 | Warnings | M013 |
| Children Acetaminophen Oral Solution | ACETAMINOPHEN | MAJOR PHARMACEUTICALS | cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 | 2025-06-09 | Warnings | M013 |
| Aspirin | ASPIRIN | Trifecta Pharmaceuticals USA LLC | 372be427-acbd-c10c-e063-6294a90a572d | 2025-06-09 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS Pharmacy | d6c8118c-bf78-4194-9b14-8de33c3ecdb7 | 2025-06-06 | Warnings | M013 |
| Dolo-NeuroBion | ACETAMINOPHEN | BENARD INDUSTRIES INC | b8310770-84d1-4a6f-8e23-9974947f92f1 | 2025-06-04 | Warnings | M013 |
| Menstrual Complete Maximum Strength | ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE | Rite Aid Corporation | 69bda7d7-8660-4e8d-b8ac-892a3b1f2124 | 2025-06-03 | Warnings | M013 |
| Kids Pain and Fever | ACETAMINOPHEN | KinderFarms, LLC | fb74e8f9-d72f-4681-90bd-df48364405b5 | 2025-06-01 | Warnings | M013 |
| Pain and Fever Childrens | ACETAMINOPHEN | P & L Development, LLC | b815fcae-8bba-4737-ac10-29a32fb69275 | 2025-05-30 | Warnings | M013 |
| Infants Pain and Fever | ACETAMINOPHEN | KinderFarms, LLC | 81cc4900-226b-4c49-ba9c-5747d2a501b1 | 2025-05-29 | Warnings | M013 |
| good sense pain relief pm extra strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Bryant Ranch Prepack | e08a7ab1-4b68-422a-97bd-2c5326633943 | 2025-05-29 | Warnings | M013 |
| Acetaminophen Gelcaps | ACETAMINOPHEN | Kroger | 30d3f2d0-da35-7f6f-e063-6294a90a9c22 | 2025-05-23 | Warnings | M013 |
| Kids Pain and Fever | ACETAMINOPHEN | Genexa Inc. | fcffa7e6-145c-6bc0-e053-6294a90a4751 | 2025-05-23 | 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 |