NDC 35916-0471-01 - DIPHENHYDRAMINE HYDROCHLORIDE
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 35916-0471
- Requested NDC
- 35916-0471-01
- Package NDCs from labels
- 35916-0471-1, 35916-0471-01
- Manufacturer
- SOFTGEL HEALTHCARE PRIVATE LIMITED
- Effective date
- 2026-01-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE - SOFTGEL HEALTHCARE PRIVATE LIMITED | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2026-01-27 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-0471-1 | DIPHENHYDRAMINE HYDROCHLORIDE | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 35916-0471 | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PRIVATE LIMITED] | 1 | Current NDC, 1 package rows | 20250427_335b6ddd-fdc8-1120-e063-6394a90add41.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 |
|---|---|---|---|---|---|---|
| CVS dye-free childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY | db5a5eff-1bb1-4d00-8c01-caae7a1c7223 | 2026-08-17 | Warnings | M012 TC2D6JAD40 |
| SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | Shield Pharmaceuticals Corp | 4b6fc81e-e3ba-4a36-834c-82766311aa73 | 2026-08-17 | Warnings | 1049909 TC2D6JAD40 |
| Leader Dry Eye Relief Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | CARDINAL HEALTH 110, LLC. DBA LEADER | 2ded4bda-b3c3-4521-8701-5c8446fd148b | 2026-08-17 | Warnings | B697894SGQ PDC6A3C0OX |
| CVS Overnight Cold and Flu Clear and Cool | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | CVS PHARMACY, INC | 2497a011-d7a0-4d69-97e2-bbf25a99b1cc | 2026-08-17 | Warnings | M012 |
| Mucus Relief Cough Cold Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | 3ef949f5-ac8c-44be-b04d-6996fa59a94b | 2026-08-17 | Warnings | M012 |
| Sinus PE Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 28a4ec37-11dd-4134-81aa-851f081bf088 | 2026-08-17 | Warnings | M012 |
| CVS Health No Drip | NASAL MIST | CVS PHARMACY,INC. | 60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa | 2026-08-17 | Warnings | M012 |
| Daytime Cold and Cough and NightTime Cold and Congestion Childrens | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreens | 2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3 | 2026-08-17 | Warnings | M012 |
| CVS Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | CVS HEALTH | f01ab8ef-d29a-4e33-8a14-4c57ccdcc0d6 | 2026-08-17 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | KROGER COMPANY | 30d50bbe-0a14-c985-e063-6294a90a47b3 | 2026-08-16 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 77f87e19-a9d5-479d-9434-bbde13210bfb | 2026-08-15 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. DBA Leader | b1c2055b-4b5a-4fa2-b600-8930c9c8524c | 2026-08-15 | Warnings | M012 |
| Nighttime HBP Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS PHARMACY | 146c9a62-0418-4b5d-9074-5be8a05f3f93 | 2026-08-15 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 610accad-2f8b-4605-9357-a58e6e18d417 | 2026-08-15 | Warnings | M012 |
| Nasal Decongestant Maximum Strength, Non-Drowsy | PSEUDOEPHEDRINE HCL | Amerisource Bergen | 1fdb1ba5-4072-4baf-9e30-f01d57bf6d82 | 2026-08-15 | Warnings | M012 |
| Cold and Flu Night | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | 32c67914-d7cf-40ee-8682-0ba8ed691287 | 2026-08-15 | Warnings | M012 |
| CVS Childrens COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | CVS PHARMACY | 27820bce-6638-4f17-ac66-62b02b76bec3 | 2026-08-14 | Warnings | M012 |
| CVS Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN | CVS PHARMACY | 333e170e-52cd-4218-8d15-0bf3c5c75cb9 | 2026-08-14 | Warnings | TC2D6JAD40 |
| BM BM63 DROPS | CEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADEN | BM Private Limited | 59006d82-610a-2e08-e063-6394a90af1ed | 2026-08-14 | Warnings | 059QF0KO0R |
| BM BM164 DROPS | ARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUM | BM Private Limited | 5902770f-eb01-d099-e063-6394a90ad3eb | 2026-08-14 | Warnings | PDC6A3C0OX |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.