equaline nighttime cold and flu relief
- Product NDC
- 41163-459
- 11-digit product format
- 411630459
- Labeler code
- 41163
- Product ID
- 41163-459_873b8a35-ae1b-4fac-b6c9-9683b5d0e830
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- United Natural Foods, Inc. dba UNFI
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-10-24
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 41163-459 | 41163-459-34 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 41163-459 | 41163-459-38 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 41163-459 | 41163-459-50 | D | Discontinued by firm | 2026-10-21 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41163-459-38 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41163-459-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41163-459-34 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41163-459-38 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41163-459-50 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41163-459-34 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41163-459-38 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41163-459-50 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41163-459-34 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41163-459-38 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41163-459-50 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41163-459-34 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41163-459-38 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41163-459-50 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41163-459-34 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41163-459-38 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41163-459-50 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41163-459-34 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41163-459-38 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41163-459-50 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41163-459-34 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41163-459-38 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41163-459-50 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41163-459-34 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41163-459-38 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41163-459-50 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41163-459-34 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41163-459-38 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41163-459-50 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41163-459-34 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41163-459-38 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41163-459-34 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 41163-459-50 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 41163-459-38 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 41163-459-34 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 41163-459-50 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- equaline nighttime cold and flu relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043400 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 05e089e7-8772-4bf4-914f-6a26067ee719 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41163-459-34 | equaline nighttime cold and flu relief | 237 mL in 1 BOTTLE | SOLUTION | 237 | 10 | |
| 41163-459-38 | equaline nighttime cold and flu relief | 296 mL in 1 BOTTLE | SOLUTION | 296 | 10 | |
| 41163-459-40 | equaline nighttime cold and flu relief | 355 mL in 1 BOTTLE | SOLUTION | 355 | 10 | |
| 41163-459-50 | equaline nighttime cold and flu relief | 355 mL in 1 BOTTLE | SOLUTION | 355 | 10 | |
| 41163-459-50 | equaline nighttime cold and flu relief | 2 in 1 CARTON | SOLUTION | 2 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 41163-459-38 | ML - Milliliter | 41163-459 | c5f35e17-c457-407d-bd42-d3fa2de67c3e | 1 | 2012-07-24 |
| 41163-459-40 | ML - Milliliter | 41163-459 | e5c61a22-564d-44bd-a83c-cdf60f4dcb60 | 1 | 2016-11-08 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41163-459 | EQUALINE NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [UNITED NATURAL FOODS, INC. DBA UNFI] | 10 | Current NDC, Legacy NDC, 5 package rows | 20241027_05e089e7-8772-4bf4-914f-6a26067ee719.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 |
|---|---|---|---|---|---|---|
| Health Smart Vaporizing Chest Rub | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Jell Pharmaceuticals Pvt Ltd. | d80cad8d-da4c-049d-e053-2a95a90ac20e | 2024-12-18 | Warnings | M012 |
| Afrin Original | OXYMETAZOLINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 8a97c012-6a47-4607-9389-58a4eed17b08 | 2024-12-18 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Orazen Inc | ecddaa3b-e18f-1c74-e053-2995a90ad86a | 2024-12-18 | Warnings | M012 |
| Rite Aid Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Rite Aid | dfedbef1-8062-432d-e053-2a95a90a09e9 | 2024-12-18 | Warnings | M012 |
| TheraCare Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Veridian Healthcare | f7801843-f96c-710e-e053-6294a90a5086 | 2024-12-18 | Warnings | M012 |
| Rugby Chest Congestion Relief G450 | GUAIFENESIN | Rugby Laboratories | a6aa8cbd-21ff-4f84-b338-c05c2d46e6df | 2024-12-18 | Warnings | M012 |
| Refenesen Mucus Relief | GUAIFENESIN | Reese Pharmaceutical Co | 861dffb7-8bf4-4f03-bcc2-ed8a35bc341d | 2024-12-18 | Warnings | M012 |
| Marcs Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Marc Glassman Inc | be3ad54f-522c-440d-b8c7-9664f6015566 | 2024-12-18 | Warnings | M012 |
| Chest Congestion Relief | GUAIFENESIN | Strategic Sourcing Services LLC | da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee | 2024-12-18 | Warnings | M012 |
| Family Wellness Chest Congestion Relief | GUAIFENESIN | Family Dollar Services Inc | 412f3459-4c22-4822-86bd-011fc3e91ca6 | 2024-12-18 | Warnings | M012 |
| Marcs Mucus Relief | GUAIFENESIN | Marc Glassman Inc | 455b9f01-206c-4534-a006-292d2bd48f47 | 2024-12-18 | Warnings | M012 |
| Leader Chest Congestion Relief G450 | GUAIFENESIN | Cardinal Health | 4586a83f-077c-4fb3-adfe-7a9497a78d97 | 2024-12-18 | Warnings | M012 |
| Foster and Thrive Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Strategic Sourcing Services LLC | 5372f764-985e-4a42-bc97-cb0dc90fcd9c | 2024-12-18 | Warnings | M012 |
| TopCare Chest Congestion and Cough Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | TOPCO ASSOCIATES LLC | 5a2d0464-038d-4c3f-b39e-ee9984fb383e | 2024-12-18 | Warnings | M012 |
| Always Save Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Valu Merch | a72b6a97-f97f-44bb-8d55-ac48b8ba45c5 | 2024-12-18 | Warnings | M012 |
| Harris Teeter Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | 4ebe1d94-bb15-4250-a4c2-8cd45743c7dd | 2024-12-18 | Warnings | M012 |
| Care One Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | RETAIL BUSINESS SERVICES , LLC | f6657dee-9f32-45b1-8e44-1ad67a4a68bd | 2024-12-18 | Warnings | M012 |
| Childrens Metapp Daytime | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Guardian Drug Company | 40565500-944b-47f2-8563-5df05469e418 | 2024-12-18 | Warnings | M012 |
| CVS Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | CVS Pharmacy, Inc. | 884abed2-e355-4134-92f1-591f3a18f71d | 2024-12-18 | Warnings | M012 |
| CVS Health Chest Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | CVS Pharmacy, Inc. | a49020e8-739e-47ec-8141-e866479a3ab3 | 2024-12-18 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 05e089e7-8772-4bf4-914f-6a26067ee719 | 10 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 05e089e7-8772-4bf4-914f-6a26067ee719 | 10 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 05e089e7-8772-4bf4-914f-6a26067ee719 | 10 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 05e089e7-8772-4bf4-914f-6a26067ee719 | 10 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 05e089e7-8772-4bf4-914f-6a26067ee719 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41163-459-34 | 41163045934 | 237 mL in 1 BOTTLE (41163-459-34) | 237 ml | 2014-07-28 | 0000-00-00 | No | No | Current |
| 41163-459-38 | 41163045938 | 296 mL in 1 BOTTLE (41163-459-38) | 296 ml | 2011-10-24 | 0000-00-00 | No | No | Current |
| 41163-459-40 | 41163045940 | 355 mL in 1 BOTTLE (41163-459-40) | 355 ml | 2012-07-11 | 0000-00-00 | No | No | Current |
| 41163-459-50 | 41163045950 | 2 BOTTLE in 1 CARTON (41163-459-50) > 355 mL in 1 BOTTLE | 2 bottle | 2014-07-28 | 0000-00-00 | No | No | Current |