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 |
|---|---|---|---|---|---|---|
| Equate Menthol Chewable Gels | MENTHOL | Walmart | 1ba4b2be-7242-0a23-e063-6294a90af29c | 2025-12-23 | Warnings | M012 |
| Walgreens Severe Menthol Throat Drops | MENTHOL | Walgreens | 21dd3c68-cbc6-4799-e063-6394a90a6972 | 2025-12-23 | Warnings | M012 |
| cherry throat relief lozenges | BENZOCAINE | Zee Medical | 499d0748-538f-678c-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| Guaiasorb DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | NuCare Pharmaceuticals, Inc. | 46a480c7-7092-b809-e063-6294a90a60cd | 2025-12-23 | Warnings | M012 |
| menthol cough drops | MENTHOL | Winco Foods | 360a6304-206d-5475-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| menthol cough drops | MENTHOL | Winco Foods | 36342d8c-34ab-6178-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| cherry cough drops | MENTHOL | Winco Foods | 37244333-1307-5121-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | Winco foods | 37718c73-880e-4a5c-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | Winco Foods | 40676ddc-577f-5cc9-e054-00144ff88e88 | 2025-12-23 | Warnings | M012 |
| Sugar Free Menthol Cough Drops | MENTHOL | Winco Foods | 3788e8b6-ab9e-1513-e054-00144ff88e88 | 2025-12-23 | Warnings | M012 |
| SAFETUSSIN Non Drowsy Cough plus chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | eeca6370-29ea-4540-8139-e8461d58a286 | 2025-12-23 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Discount Drug Mart | dd31f86b-f59e-459a-8e5f-176828706a4a | 2025-12-23 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Discount Drug Mart | f8e7a08e-7422-4a1b-bfec-93e0b50d10cd | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | ab45ae97-7951-4058-e053-2995a90a7b2e | 2025-12-23 | Warnings | M012 |
| Childrens Chest Congestion Relief Grape | GUAIFENESIN | Discount Drug Mart | 3e5d245f-515c-4106-a855-fb97681b646a | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | ab45ed16-86bb-3faf-e053-2995a90acfbc | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | a7999da7-148a-4c6d-a2ea-0f4cc1d5b283 | 2025-12-23 | Warnings | M012 |
| Safetussin High Blood Pressure and diabetes Cough, Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 279e309c-040d-4001-808d-b7d986a9a1d8 | 2025-12-23 | Warnings | M012 |
| Sinus PE Head Congestion and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 76fd1f8e-2670-421c-a9e6-c8adefb7962e | 2025-12-23 | Warnings | M012 |
| Leader Cough Drops Vanilla Honey | MENTHOL | Cardinal Health 110, LLC. DBA Leader | 1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e2 | 2025-12-22 | Warnings | 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 |