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 |
|---|---|---|---|---|---|---|
| Childrens Pain Relief Dye free | ACTEMINOPHEN | BETTER LIVING BRANDS LLC. | 41f504d1-29c4-f075-e063-6394a90ad64c | 2026-04-11 | Warnings | M013 |
| Dr. Simi Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Farmacias De Similares TX LLC | 4f1e1f1a-44f4-2356-e063-6294a90a8cdd | 2026-04-10 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Akron Pharma Inc. | e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed | 2026-04-10 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Akron Pharma Inc. | 28413cb3-22c4-40e2-ad6b-42beb438dea3 | 2026-04-10 | Warnings | M013 |
| Pain Reliever Childrens | ACETAMINOPHEN | H E B | 7e43de11-d20b-4920-a04d-3c1b5d35e005 | 2026-04-09 | Warnings | M013 |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Navajo Manufacturing Company Inc. | f7e572e9-82a7-2127-e053-6394a90ab01a | 2026-04-08 | Warnings | M013 |
| Bayer Genuine Aspirin | ASPIRIN | Navajo Manufacturing Company Inc. | f6f2ce71-5728-aefb-e053-6394a90a20e4 | 2026-04-08 | Warnings | M013 |
| Midol | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Navajo Manufacturing Company Inc. | cabd10f2-a91e-4406-9249-915e306c867b | 2026-04-08 | Warnings | M013 |
| Aspirin | ASPIRIN | HyVee Inc | 3730ee46-b241-44eb-94fa-52b9d12a9c35 | 2026-04-08 | Warnings | M013 |
| Aspirin | ASPIRIN | Walgreen Company | 82cc404b-fcf5-4e48-ab1a-09d8c47f9e04 | 2026-04-08 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | 9efcce86-dd57-4ea2-ad31-d2038eb61bf1 | 2026-04-07 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 1b164780-ec84-4187-8afa-6f8a0da550fc | 2026-04-07 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 201b860d-dc3c-4380-affa-e757bf2103cf | 2026-04-07 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Walgreens | 6e7475e2-81a9-43b5-9b81-b58ab761a6f4 | 2026-04-07 | Warnings | M013 |
| Pain Relief Aspirin Low Dose | ASPIRIN | Rite Aid Corporation | 503408ed-e799-48a0-8d38-3034f4a0ead5 | 2026-04-02 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | Lidl US LLC | 468f4a2f-60f7-4808-95d7-a00be1bb112f | 2026-04-02 | Warnings | M013 |
| Childrens Acetaminophen | ACETAMINOPHEN | Grocery Outlet, Inc. | 44de6f5a-0b5c-6c28-e063-6394a90a7e0b | 2026-04-02 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | ARMY AND AIR FORCE EXCHANGE SERVICE | 26ae0d0a-34c0-4d16-951a-8d5a463c808b | 2026-04-02 | Warnings | M013 |
| Pain Reliever plus Sleep Aid NightTime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Kroger Company | 286ca3b3-2ecc-4f90-adb5-d7bc0ba0b4d0 | 2026-04-02 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | COSTCO WHOLESALE CORPORATION | c8a8986b-1ab4-9da0-71da-42595db08b44 | 2026-04-02 | 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 |