Diphenhydramine HCL
- Product NDC
- 66424-021
- 11-digit product format
- 664240021
- Labeler code
- 66424
- Product ID
- 66424-021_2ba30474-41ba-6c1a-e063-6394a90a9631
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCL
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- SDA Laboratories, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-01-27
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 66424-021-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 66424-021-01 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 66424-021-10 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 66424-021-01 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 66424-021-10 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 66424-021-01 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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
- Diphenhydramine HCL
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1020477 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 437e6a13-a4ff-4f98-8973-042f224ee85e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 66424-021-01 | 2023-06-13 | Drug Facts |
| 66424-021-10 | 2023-06-13 | Drug Facts |
| 66424-021-01 | 2020-01-31 | Drug Facts |
| 66424-021-10 | 2020-01-31 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66424-021-01 | Diphenhydramine HCL | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | 3 | |
| 66424-021-10 | Diphenhydramine HCL | 1000 in 1 BOTTLE, PLASTIC | CAPSULE | 1000 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66424-021-01 | EA - Each | 66424-021 | 9776653f-7c63-4b8b-a643-b1ff64504064 | 1 | 2012-07-24 |
| 66424-021-10 | EA - Each | 66424-021 | fa4dd348-3929-4217-a7fb-c7f312f780c8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Foster and Thrive Cherry Cough Drops | MENTHOL | McKesson | 49eefa70-cef9-d7ec-e063-6294a90ac321 | 2026-02-03 | Warnings | M012 |
| Foster and Thrive Honey Lemon Cough Drops | MENTHOL | McKesson | 49f13ee3-6bb3-e500-e063-6394a90a152d | 2026-02-03 | Warnings | M012 |
| Daytime Cold and Flu Mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 63cb19d4-2306-4723-a95e-9d2d8b9eccd0 | 2026-02-03 | Warnings | M012 |
| Foster and Thrive SF Honey Lemon Cough Drops | MENTHOL | McKesson | 49f41c30-f806-44ba-e063-6394a90a5a67 | 2026-02-03 | Warnings | M012 |
| Nighttime Cold and Flu Mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | b9af8ab4-a7cb-4adf-9f6f-398c6bb7f853 | 2026-02-03 | Warnings | M012 |
| allergy relief | DIPHENHYDRAMINE HCL | Meijer Distribution Inc | 7c2fc244-bfc5-4e3c-aa90-8bc3d067b64f | 2026-02-03 | Warnings | M012 |
| Cold and Allergy D | PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL | Walgreen Company | 832ac849-7f4a-489a-a704-9d4388a75a71 | 2026-02-03 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 987f908b-7af7-4705-bfb4-c48d771c380d | 2026-02-03 | Warnings | M012 |
| tussin dm nighttime max | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | HyVee Inc | 1f3fb451-84c9-432e-ac67-2694dd66c815 | 2026-02-03 | Warnings | M012 |
| Robafen DM Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Major Pharmaceuticals | 7c9660b7-cb00-449b-b65f-aa42d8ce1942 | 2026-02-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 6b0d261f-fc27-4b34-88b1-cd3d72766760 | 2026-02-02 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | ebfcb699-3369-4697-9841-44015b1c9808 | 2026-02-02 | Warnings | M012 |
| Cherry Sore Throat Lozenges | BENZOCAINE, MENTHOL | Meijer Distribution Inc. | 2f6de590-7cad-25d7-e054-00144ff8d46c | 2026-02-02 | Warnings | M012 |
| Mixed Berry Sore Throat and Cough lozenge | DEXTROMETHORPHAN HYDROBROMIDE | Meijer Distribution, Inc. | 304ff4db-201a-60a4-e054-00144ff8d46c | 2026-02-02 | Warnings | M012 |
| Allergy Relief Plus Congestion | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreen Company | 38d91107-d95c-40f2-a27e-561f951e519d | 2026-02-02 | Warnings | M012 |
| Tussin Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | HyVee Inc | 85252999-3463-45fe-b4a9-7a97960b41b1 | 2026-02-02 | Warnings | M012 |
| Amazon Basics Cherry Cough Drops 30ct | MENTHOL | Amazon | 3e74e209-c9c9-3979-e063-6294a90afcfa | 2026-02-01 | Warnings | M012 |
| Amazon Basics Honey Lemon Cough Drops 30ct | MENTHOL | Amazon | 3e75838b-e1c9-2d42-e063-6294a90aab82 | 2026-02-01 | Warnings | M012 |
| cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | HyVee Inc | 5110526f-51fd-401e-ba52-520674d34f37 | 2026-02-01 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Amazon.com Service LLC | 673996ab-6e57-4feb-8af3-d8b474741a8d | 2026-01-30 | Warnings, Adverse reactions | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 3ac0beba-303d-404e-bfec-0cf8c0e8624d | 12 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 5 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 5 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 5 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 5 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 5 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 5 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 3dbdf020-ca17-1197-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 489645ad-d7da-5f52-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 489645ad-d7da-5f52-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 3dbdf020-ca17-1197-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 489645ad-d7da-5f52-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 3dbdf020-ca17-1197-e054-00144ff8d46c | 4 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 437e6a13-a4ff-4f98-8973-042f224ee85e | 3 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 437e6a13-a4ff-4f98-8973-042f224ee85e | 3 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 437e6a13-a4ff-4f98-8973-042f224ee85e | 3 |
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | c46e1443-dffe-47a9-bc9a-acbe3a8b0b41 | 1 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | c46e1443-dffe-47a9-bc9a-acbe3a8b0b41 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 66424-021-01 | 66424002101 | 100 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-01) | 100 capsule | 2010-01-27 | No | No | Current |
| 66424-021-10 | 66424002110 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-10) | 1000 capsule | 2010-01-27 | No | No | Current |