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 |
|---|---|---|---|---|---|---|
| Lil Drug Store Aspirin 325 | ASPIRIN | Lil Drug Store Products, Inc | de59aae2-f794-4243-acc8-37a10e27abde | 2023-12-15 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN TABLET, EXTRA STRENGTH | Lil' Drug Store Products, Inc. | f0fdab5a-9d07-57aa-e053-2a95a90adc7f | 2023-12-15 | Warnings | M013 |
| BC Cherry | ASPIRIN AND CAFFEINE | Lil' Drug Store Products, Inc | 79ea721b-d656-44f7-9d13-390debee7be0 | 2023-12-15 | Warnings | M013 |
| Alka-Seltzer | BUFFERED ASPIRIN | Lil' Drug Store Products, Inc. | 0c7a60e7-0bde-9aa2-e063-6294a90a3209 | 2023-12-14 | Warnings | M013 |
| Circle K Aspirin 325 | ASPIRIN | Lil Drug Store Products, Inc | 4cd306e3-2119-4272-9da4-a848fe2746fa | 2023-12-14 | Warnings | M013 |
| Circle K Pain Reliever Extra Strength | ACETAMINOPHEN | Lil' Drug Store Products, Inc. | f2359bc3-901f-4ecb-b402-cb2fe404a935 | 2023-12-14 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | c55b8f9d-1396-43c0-acc9-5e3485eadb07 | 2023-12-08 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 775519ad-5683-451f-9bfc-5fafc70c68ec | 2023-12-08 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | WALGREEN CO. | c20c814b-35f5-4c46-e053-2a95a90a50f2 | 2023-12-08 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Better Living Brands LLC | f9859be4-6d0b-2ab8-e053-6294a90aa862 | 2023-12-06 | Warnings | M013 |
| Aurophen Regular Strength | ACETAMINOPHEN | KROGER COMPANY | b9b7b849-c3b3-9af7-e053-2a95a90a0077 | 2023-12-06 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | KROGER COMPANY | cf649478-57d2-cc88-e053-2a95a90ad1ba | 2023-12-06 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | KROGER COMPANY | b9b6f878-1ec8-3dc0-e053-2995a90a5414 | 2023-12-06 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALGREEN CO. | a48c522c-76c5-49f8-8c4d-3ee6b221e6f3 | 2023-12-06 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALGREEN CO. | cc939a7c-ce56-5dd6-e053-2995a90aa8af | 2023-12-06 | Warnings | M013 |
| Alka-Seltzer Original Flavor | BUFFERED ASPIRIN, EFFERVESCENT TABLET | Lil' Drug Store Products, Inc. | ea5df8be-a08c-5fa3-e053-2995a90a0bac | 2023-12-06 | Warnings | M013 |
| Ringl | ACETAMINOPHEN | Sato Pharmaceutical Co., Ltd. | ba5a0286-3e0f-4bef-96e5-29d92f51f432 | 2023-12-06 | Warnings | M013 |
| Pain Relief Childrens | ACETAMINOPHEN | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 41633554-474e-4d3c-9187-d90487d2ae8c | 2023-12-06 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Family Dollar Stores, LLC | f86dcbb8-debc-4bce-e053-6294a90a7a02 | 2023-12-05 | Warnings | M013 |
| Sanatos Multi Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Pharmadel LLC | 0a5fc0ef-ba34-bb0b-e063-6394a90af7d9 | 2023-12-01 | 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 |