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 |
|---|---|---|---|---|---|---|
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | P & L Development, LLC | 55e996cd-ef22-4e09-a05c-8aa994e4540b | 2026-06-12 | Warnings | M013 |
| CHILDRENS TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 3162733b-9382-39f1-e063-6294a90ac420 | 2026-06-12 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Dr. Reddy's Laboratories Inc. | 9769e0c0-2f4c-3b7a-1a65-c98fbce11681 | 2026-06-12 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | NuCare Pharmaceuticals, Inc. | 54010ddf-25d1-2016-e063-6294a90a877d | 2026-06-11 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 983debdf-4a61-4dde-ba34-567fdd17720e | 2026-06-11 | Warnings | M013 |
| Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALGREENS | 40b4fe91-b1dd-147c-e063-6294a90a807d | 2026-06-09 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PUBLIX SUPERMARKETS, INC | 3f17fa06-4932-b8ec-e063-6294a90a0381 | 2026-06-09 | Warnings | M013 |
| Sleep Aid Plus Pain Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreen Company | e3929179-dad2-4f7e-a971-dbf80f2b5e1b | 2026-06-08 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | Pinnacle RX LLC | 53c11fb4-ba31-b5e5-e063-6394a90a9c1a | 2026-06-08 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreen Company | 9655c38a-126b-459e-b31d-0aa33d9eb522 | 2026-06-08 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | Aurohealth LLC | dce938f5-eeba-4a76-9261-2b1324c39a31 | 2026-06-08 | Warnings | M013 |
| Childrens Mapap | ACETAMINOPHEN | Bryant Ranch Prepack | 69c90cc8-846a-42cf-933a-108671689e8f | 2026-06-05 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Rugby Laboratories | 63fcd93a-b1db-44ba-8f2b-055a7deb205d | 2026-06-04 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | ASCLEMED USA INC. | 707a9ea7-8f4e-4274-97bd-b8071a0ee06b | 2026-06-04 | Warnings | M013 |
| Aspirin Adult low dose | ACETYLSALICYCLIC ACID | Medline Industries, LP | 6dd6501f-841c-4994-e053-2a91aa0ae231 | 2026-06-04 | Warnings | M013 |
| Medline | ACETAMINOPHEN | Medline Industries, LP | fc5e6f2a-e813-0666-e053-6394a90a66a7 | 2026-06-04 | Warnings | M013 |
| Medline | ACETAMINOPHEN | Medline Industries, LP | fc5d92c2-4bbe-8ad1-e053-6294a90a65b6 | 2026-06-04 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | Unit Dose Solutions, Inc. | 537219ac-552a-a30e-e063-6394a90aa9d1 | 2026-06-04 | Warnings | M013 |
| Pain Relief childrens | ACETAMINOPHEN | CVS PHARMACY | ff878f56-125a-4de7-b063-029f7030733d | 2026-06-04 | Warnings | M013 |
| Back and Body Extra Strength | ASPIRIN, CAFFEINE | CVS Pharmacy | 749e2be2-594a-4052-8fa5-45c9ade2d23c | 2026-06-03 | 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 |