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 |
|---|---|---|---|---|---|---|
| LOW DOSE ASPIRIN | ASPIRIN | Bryant Ranch Prepack | 64c28b38-23bb-4c7e-9c19-1d1f0d597528 | 2024-01-18 | Warnings | M013 |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | e0dd4c04-6811-38a1-e053-2995a90aa3c9 | 2024-01-17 | Warnings | M013 |
| Regular Strength Acetaminophen | ACETAMINOPHEN | CARDINAL HEALTH | bdf8c511-ce25-0e30-e053-2a95a90a33f6 | 2024-01-10 | Warnings | M013 |
| Extra Strength Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2560126e-a54a-4a47-9631-a1bca42f5277 | 2024-01-10 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | A-S Medication Solutions | ee4451c9-4d0f-4373-8f64-fcc1f9dd5856 | 2024-01-05 | Warnings | M013 |
| Pharbetol | ACETAMINOPHEN | Proficient Rx LP | 51ba690e-d76b-41c6-a083-8bc803e1faa2 | 2024-01-01 | Warnings | M013 |
| MEDI-FIRST Non-Aspirin Extra Strength | ACETAMINOPHEN | Proficient Rx LP | 9071b047-5463-4f65-b775-bfb0ce066527 | 2024-01-01 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | TIME CAP LABORATORIES, INC | 1acc8c1a-c746-4635-800c-de1ad758fce0 | 2023-12-30 | Warnings | M013 |
| MAX Cold, Flu, and Sore Throat | ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL | H E B | 9b09b660-0758-48dc-84c9-26cdd2aacc03 | 2023-12-29 | Warnings | M013 |
| NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | DeMoulas Market Basket | eb24323f-82a1-4ba3-9359-fe81571c3fba | 2023-12-29 | Warnings | M013 |
| Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Salado Sales, Inc. | e6c3e545-b2ad-47f0-8318-c134a8e24f5b | 2023-12-29 | Warnings | M013 |
| Daytime Non-Drowsy COLD/FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Salado Sales, Inc. | e181b371-78c7-4163-865d-acc064be33ca | 2023-12-29 | Warnings | M013 |
| Childrens Pain and Fever Cherry flavor | ACETAMINOPHEN | Walgreen Company | 64c65244-f7a3-401b-b83a-bf66d45268e2 | 2023-12-29 | Warnings | M013 |
| Nite-Time COLD/FLU ORIGINAL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Salado Sales, Inc. | fcd24753-b42b-4d05-8379-0ec0351ab217 | 2023-12-29 | Warnings | M013 |
| NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | DeMoulas Market Basket | e772cdf5-d01d-4752-8cfb-7e7f4d7a8dd0 | 2023-12-29 | Warnings | M013 |
| Childrens Pain and Fever, Grape flavor | ACETAMINOPHEN | Walgreen Company | 0995d69f-61aa-40b0-b095-bb8595caf773 | 2023-12-29 | Warnings | M013 |
| DAY-TIME Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | ce900e42-d0c8-408d-a1c3-3a9bef1c97ee | 2023-12-29 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | DOLGENCORP, INC. | 06553550-5685-f3c3-e063-6394a90aef07 | 2023-12-22 | Warnings | M013 |
| Tension Headache Pain Relieving Aid | ACETAMINOPHEN,CAFFEINE | WAL-MART STORES INC | 00fadd26-a6eb-dc5e-e063-6394a90a3cca | 2023-12-15 | Warnings | M013 |
| Dye-Free Aspirin 81 | ASPIRIN | WALGREENS | d71a9d3a-cd28-14a8-e053-2995a90a832b | 2023-12-15 | 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 |