ALKA SELTZER PLUS Cold Day and Night Effervescent
- Product NDC
- 71992-154
- 11-digit product format
- 719920154
- Labeler code
- 71992
- Product ID
- 71992-154_086318bd-5067-477e-e063-6294a90ab2dd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sincronia Logistica, S.A. de C.V.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-07-02
- Substance
- ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE
- Active strength
- 325; 10; 7.8 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [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
- 2027-12-31
- 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
- ALKA SELTZER PLUS Cold Day and Night Effervescent
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASPIRIN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| PHENYLEPHRINE BITARTRATE | 7.8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R16CO5Y76E | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 27O3Q5ML57 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1536498 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c478df69-823a-4112-8f44-323249a9f38f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71992-154-20 | ALKA SELTZER PLUS Cold Day and Night Effervescent | 20 in 1 CARTON | TABLET | 20 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71992-154 | ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT (ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) TABLET [SINCRONIA LOGISTICA, S.A. DE C.V.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231024_c478df69-823a-4112-8f44-323249a9f38f.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 |
|---|---|---|---|---|---|---|
| NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Lil' Drug Store Products, Inc. | e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b | 2023-10-02 | Warnings | M012 |
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | PD-Rx Pharmaceuticals, Inc. | ac8c0c15-b305-47f2-8712-e4b53636f7fa | 2023-10-02 | Warnings | M012 |
| Maximum strength Day cold and flu and Night severe cold and flu | ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS | TIME CAP LABORATORIES,INC | fff69901-965c-5372-e053-6394a90a29c2 | 2023-09-18 | Warnings | M012 |
| Tussin Mucus and Chest Congestion Sugar Free | GUAIFENESIN | AARNA USA, Inc. | 6e488782-0138-436d-a9f0-0ec5bc9daedd | 2023-05-15 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | KROGER COMPANY | 813b1db2-a177-77c6-e053-2a91aa0ac73b | 2023-01-17 | Warnings | M012 |
| MUCUS RELIEF DM | DEXTROMETHORPHAN HBR/GUAIFENESIN | KROGER COMPANY | 813baf42-edb0-33a9-e053-2a91aa0a8599 | 2023-01-17 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H-E-B | db19b8c7-0334-0664-e053-2a95a90ad61f | 2023-01-14 | Warnings | M012 |
| Nightime | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | H-E-B | db44560b-da02-74c9-e053-2a95a90af0b6 | 2023-01-13 | Warnings | M012 |
| DAYTIME COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | dbf5656b-9105-871b-e053-2995a90a4941 | 2023-01-03 | Warnings | M012 |
| DAYTIME-NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | KROGER | a2508699-08c0-4a22-e053-2a95a90a8a6d | 2022-11-02 | Warnings | M012 |
| GUAIFENESIN | GUAIFENESIN | PAI Holdings, LLC dba PAI Pharma | c2e53fb5-2798-47c8-9285-d1077d46e629 | 2022-06-14 | Warnings | M012 |
| Mucus Relief DM | MUCUS RELIEF DM | TopCo Associates, LLC | 71674a9b-89ed-43d1-aadb-b9311fdfbdf9 | 2022-06-07 | Warnings | M012 |
| Daytime Nighttime Cold and Flu Relief Combo Pack | DAYTIME NIGHTTIME COLD AND FLU | Allegiant Health | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 2022-05-19 | Warnings | M012 |
| Mucus Relief DM Immediate Release | MUCUS RELIEF DM | Good Sense | 26a199bf-57e5-4f36-b40c-83a1187e4870 | 2022-05-18 | Warnings | M012 |
| Mucus Relief DM Immediate Release | MUCUS RELIEF DM | Allegiant Health | 731f8608-ad5b-491e-a4d4-2bb0c423fed5 | 2022-05-18 | Warnings | M012 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b3c229a4-c772-70fb-e053-2a95a90a72db | 2022-03-11 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Good Sense | f88e2654-8e97-4cf6-9c36-01aeb51a9102 | 2021-11-30 | Warnings | M012 |
| Cold Medicine | COLD MEDICINE | Allegiant Health | 443fbc44-2c33-4316-ad31-dcc5a5aa8f52 | 2021-11-23 | Warnings | M012 |
| Decongestant PE Non Drowsy | PHENYLEPHRINE HCL | Allegiant Health | 7a3098b4-381c-4f32-97a7-87b53fd64428 | 2021-06-16 | Warnings | M012 |
| Mucus Relief Immediate Release | GUAIFENESIN 400MG | Good Sense | e7c68746-7ec0-46cf-b4a3-174fab819b5e | 2021-05-05 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1536498 | aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | c478df69-823a-4112-8f44-323249a9f38f | 4 |
| 1536498 | aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | c478df69-823a-4112-8f44-323249a9f38f | 4 |
| 1536498 | ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | c478df69-823a-4112-8f44-323249a9f38f | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71992-154-20 | 71992015420 | 20 TABLET in 1 CARTON (71992-154-20) | 20 tablet | 2018-07-02 | 0000-00-00 | No | No | Current |