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 Regular Strength | ASPIRIN | Rite Aid Corporation | 879e2258-f61b-47ad-a4b1-7d1e78823570 | 2026-03-05 | Warnings | M013 |
| Aspirin | ASPIRIN | ARMY AND AIR FORCE EXCHANGE SERVICE | 87c580d3-6009-4be9-aea7-13539fbe6e31 | 2026-03-05 | Warnings | M013 |
| Aspirin Low Dose Chewable Orange | ASPIRIN | MAJOR PHARMACEUTICALS | fb3a8e38-e991-49c9-93dc-1d29c0a97ba3 | 2026-03-05 | Warnings | M013 |
| Infants Pain and Fever | ACETAMINOPHEN | Kroger | 41e149df-4140-95cc-e063-6294a90a866b | 2026-03-03 | Warnings | M013 |
| Medique Pain Off | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Sportpharm LLC | 2b35acdc-ff88-46e6-a108-5240aac1d53f | 2026-03-03 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Best Choice (Valu Merchandisers Company) | a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c07 | 2026-03-03 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | HyVee Inc | 6820a515-4004-407b-969b-c4069dc0c3b5 | 2026-02-26 | Warnings | M013 |
| Acetaminophen, Diphenhydramine Hydrochloride | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | LEADER/ Cardinal Health 110, Inc. | 7be4d67e-1af9-f059-e053-2991aa0a382e | 2026-02-26 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16 | 2026-02-26 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 1f4ac0e6-e986-4c22-8248-0691d64e1a30 | 2026-02-26 | Warnings | M013 |
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | Discount Drug Mart | f413a617-1166-4940-b6ec-fae32238a780 | 2026-02-26 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 19735691-33f3-4e19-85ad-e5f270251ec5 | 2026-02-26 | Warnings | M013 |
| Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Kroger | 44520aa1-b63f-4239-e063-6394a90a5e14 | 2026-02-25 | Warnings | M013 |
| Leader Extra Strength Effervescent Antacid and Pain Reliever | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Cardinal Health | c5d7bf5f-3e59-52f2-e053-2a95a90a4a00 | 2026-02-25 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 12fd643d-7c60-453f-a81f-407ed20e8725 | 2026-02-25 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d96a1531-772b-4a5c-89e4-66fff1fa3d78 | 2026-02-25 | Warnings | M013 |
| Gentle Care Kit | ZINC OXIDE | Kenvue Brands LLC | 4b8f7a5a-2fc4-ea00-e063-6294a90ab95b | 2026-02-24 | Warnings | M013 |
| Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE | Haleon US Holdings LLC | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 2026-02-23 | Warnings | M013 |
| Excedrin Extra Strength and Excedrin Tension Headache | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 2026-02-23 | Warnings | M013 |
| Equate Childrens Pain and Fever | ACETAMINOPHEN | Wal-Mart Stores Inc | 40eedfe9-54e1-40a2-b4a2-55ff708b89cd | 2026-02-23 | 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 |