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 |
|---|---|---|---|---|---|---|
| topcare infants pain and fever | ACETAMINOPHEN | Topco Associates LLC | a1145ac3-3e55-4bd5-a53e-6cf869add9a1 | 2024-07-02 | Warnings | M013 |
| Drug Mart Effervescent Pain Relief | ASPIRIN | Discount Drug Mart Inc | 1c35f394-a221-6531-e063-6394a90acb8a | 2024-07-01 | Warnings | M013 |
| Aspirin | ASPIRIN | Wildman Business Group | cdbfcf14-8685-40a9-9778-a3b4329dc1ad | 2024-07-01 | Warnings | M013 |
| Back Pain Relief Extra Strength Doans | MAGNESIUM SALICYLATE | Wildman Business Group | 2e17664f-a83f-48d1-8b2b-37f41eea65b6 | 2024-07-01 | Warnings | M013 |
| Meijer Effervescent Pain Relief | ASPIRIN | Meijer Distribution Inc | 17553911-e0fc-e355-e063-6394a90af7b8 | 2024-06-28 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 4fb4f4b2-c238-4933-b874-08def3b34a28 | 2024-06-26 | Warnings | M013 |
| good neighbor pharmacy pain and fever childrens | ACETAMINOPHEN | Amerisource Bergen | ca0833ef-837b-47dc-8676-e016af96622c | 2024-06-26 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 4a030c3e-8104-4a0a-98c5-6ab469451f20 | 2024-06-26 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | Padagis Israel Pharmaceuticals Ltd | a426dd82-b2d6-405e-b0af-cfb1310a6e19 | 2024-06-26 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALMART INC. (see also Equate) | 7d86a03f-74f4-4b24-b6a6-8747acfe905e | 2024-06-26 | Warnings | M013 |
| leader childrens pain and fever | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 5bcc5da9-7e64-4308-a5be-2f47a8ca774d | 2024-06-25 | Warnings | M013 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | NuCare Pharmaceuticals,Inc. | 9e691264-d48a-6b48-e053-2995a90a9352 | 2024-06-20 | Warnings | M013 |
| Aspirin | REGULAR STRENGTH ENTERIC COATED ASPIRIN | NuCare Pharmceuticals,Inc. | a0705f4f-55cb-214a-e053-2995a90aa680 | 2024-06-20 | Warnings | M013 |
| Extra Strength Pain Reliever | ACETAMINOPHEN 500 MG | Lil' Drug Store Products, Inc. | ee8e0e79-4da4-101f-e053-2a95a90a30a4 | 2024-06-19 | Warnings | M013 |
| Extra Strength Headache Relief | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE | Lil' Drug Store Products, Inc. | b3a06e4b-0b31-4e2a-8dd1-9de85760477b | 2024-06-19 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | Meijer Distribution Inc | 43c3fe72-a4ef-48a6-bc22-a644919c0c5c | 2024-06-17 | Warnings | M013 |
| Aspirin Regular Strength | ASPIRIN | RETAIL BUSINESS SERVICES , LLC. | 093182a6-3ed8-5a3f-e063-6294a90a354a | 2024-06-14 | Warnings | M013 |
| ACETAMINOPHEN PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 093199be-e92a-6f60-e063-6294a90a8533 | 2024-06-14 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | RETAIL BUSINESS SERVICES , LLC. | 09315a3d-bb2d-4f06-e063-6294a90a3bd3 | 2024-06-14 | Warnings | M013 |
| Pain Relief Regular Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION INC | 613bc633-0426-41a7-aea9-9ff56311b607 | 2024-06-13 | 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 |