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 |
|---|---|---|---|---|---|---|
| Nighttime Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | P & L Development, LLC | 8d27b94d-23a1-4e6c-a064-79e2580f7e2e | 2024-04-15 | Warnings | M012 |
| Severe Cold and Cough Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | P & L Development, LLC | 2af496a1-6fdd-4acf-9944-8b7cdf302275 | 2024-04-15 | Warnings | M012 |
| Childrens Dye Free Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | P & L Development, LLC | 1c4d09ed-4e0f-430d-b17f-6a23f996a55d | 2024-04-15 | Warnings | M012 |
| Theraflu ExpressMax Daytime Nighttime Value Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 2024-04-10 | Warnings | M012 |
| Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 2024-04-10 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE | Harris Teeter, LLC | ec603195-eb36-4b5c-bc9b-c2074205b2b2 | 2024-04-09 | Warnings | M012 |
| Daytime Cold and Flu Non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | 9b0648ac-0ce3-4eaa-8977-26ae864f034d | 2024-04-09 | Warnings | M012 |
| Theraflu Severe Cold Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | f147d82e-4429-4c7b-bd2b-e21a09f21c92 | 2024-04-09 | Warnings | M012 |
| FLONASE Headache and Allergy Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 282c103c-3888-4a35-a5b1-d492ed6892c1 | 2024-04-08 | Warnings | M012 |
| ROBITUSSIN COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 4908b326-e1da-44ca-8087-7e41a16c27b0 | 2024-04-08 | Warnings | M012 |
| Robitussin Direct Sore Throat Pain | ACETAMINOPHEN | Haleon US Holdings LLC | 1b512078-24c3-4b80-8f2c-d6824d367f25 | 2024-04-08 | Warnings | M012 |
| Mucus Relief Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENSIN | H E B | 9ba5ca1b-2e3c-439e-8887-c26f144b88ef | 2024-04-08 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | 12ace982-bd47-49b0-ba1b-e0a29d42f1d6 | 2024-04-08 | Warnings | M012 |
| Allergy Childrens | DIPHENHYDRAMINE HYDROCHLORIDE | H E B | ab28cbc4-7a6f-46e9-8616-be78e8cb24fe | 2024-04-08 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | bd19b1f2-d9d3-4dab-8181-605f769ab62f | 2024-04-08 | Warnings | M012 |
| Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | 9f533092-060c-4379-9a77-ecfea8aa46e1 | 2024-04-08 | Warnings | M012 |
| Robitussin Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 66360295-f364-479a-8b49-c12b21918279 | 2024-04-06 | Warnings | M012 |
| Robitussin Peak Cold Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | 8c0a2424-e8ac-d91c-b46d-a5ee29f91936 | 2024-04-06 | Warnings | M012 |
| Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | e7cf7c5d-5c9a-4201-9e30-1cd616071855 | 2024-04-06 | Warnings | M012 |
| Robitussin Medi-Soothers | DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL | Haleon US Holdings LLC | 4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5 | 2024-04-06 | 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 |