Diphenhydramine HCl
- Product NDC
- 0121-1730
- 11-digit product format
- 001211730
- Labeler code
- 0121
- Product ID
- 0121-1730_d56f4fe1-e90c-4e35-a488-12c93938a3dd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-06-18
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/10mL
- 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
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 | 0121-1730 | 0121-1730-30 | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
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 | 25 mg/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049906 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-1730-00 | Diphenhydramine HCl | 10 in 1 CASE | SOLUTION | 10 | 5 | |
| 0121-1730-00 | Diphenhydramine HCl | 10 in 1 TRAY | SOLUTION | 10 | 5 | |
| 0121-1730-10 | Diphenhydramine HCl | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | 5 | |
| 0121-1730-30 | Diphenhydramine HCl | 3 in 1 CASE | SOLUTION | 3 | 5 | |
| 0121-1730-30 | Diphenhydramine HCl | 10 in 1 TRAY | SOLUTION | 10 | 5 |
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 |
|---|---|---|---|---|---|---|
| Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | fe44d1ee-1e03-b74f-e053-6294a90a8bb4 | 2026-05-19 | Warnings | M012 |
| MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 325b41e1-f8d2-02ee-e063-6394a90aafff | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 326f1fd3-73ab-e515-e063-6294a90ab222 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 6c85df30-a601-4de6-9fd6-818265d799ff | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 7050b583-c09b-4457-9a9c-70c0923b62c0 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 27312ee4-d1f4-4a95-9c45-91fa5a01f5ba | 2026-05-19 | Warnings | M012 |
| Mucinex Rapid Clear Daytime Pain, Headache, and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 37de53a7-5546-3804-e063-6294a90a0fb5 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 36b07e49-c72c-45e5-e063-6394a90a804a | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus Max Clear and Cool Severe Congestion | OXYMETAZOLINE HCI | Reckitt Benckiser LLC | 2ee95e17-bd94-d717-e063-6294a90a2173 | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus Max Sinus Pressure Severe Congestion | OXYMETAZOLINE HCI | Reckitt Benckiser LLC | 2eeafd83-230c-af92-e063-6294a90a984e | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Congestion and Headache Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7017328-f8af-4601-9232-dc1104feaa0a | 2026-05-19 | Warnings | M012 |
| Mucinex Rapid Clear Pain Headache and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 32375b12-75ed-d605-e063-6294a90ad004 | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 07da45b5-d05e-41b1-b233-f7034d556a8d | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | ad4e0e4d-cc1f-4176-835f-3ba76564c634 | 2026-05-19 | Warnings | M012 |
| Mucinex Childrens Mini Melts Cold and Flu | ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 401fe0a0-ec97-5248-e063-6394a90af27f | 2026-05-19 | Warnings | M012 |
| Childrens Cough and Congestion, Childrens Cold and Cough Day, Night | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN | WALMART INC. | 312ae879-1124-40a4-b2ba-3f3070840021 | 2026-05-19 | Warnings | M012 |
| GOOD SENSE DAYTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | L. Perrigo Company | 2597e84c-18b4-41a9-8e6a-ff0c4c1f0612 | 2026-05-18 | Warnings | M012 |
| Childrens Mucus Cough and Congestion Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 8b5d391b-6c23-44c3-81d0-c08822bf6d01 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Night Time Multi-Symptom Cold | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | e048cd53-a3cd-484f-a972-4cb49791dba3 | 2026-05-18 | Warnings | M012 |
| Mucinex Childrens Cough | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | b8132c81-5291-431a-ad3a-ec8a3eb21c19 | 2026-05-18 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc | 5 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc | 5 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc | 5 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc | 5 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc | 5 |
| 1049906 | diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution | PSN | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2 |
| 1049906 | diphenhydramine hydrochloride 2.5 MG/ML Oral Solution | SCD | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2 |
| 1049906 | diphenhydramine HCl 12.5 MG per 5 ML Oral Solution | SY | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2 |
| 1049906 | diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution | SY | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2 |
| 1049906 | diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution | SY | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0121-1730-00 | 00121173000 | 10 TRAY in 1 CASE (0121-1730-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1730-10) | 10 tray | 2020-06-18 | 0000-00-00 | No | No | Current |
| 0121-1730-10 | 00121173010 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | Historical | ||||
| 0121-1730-30 | 00121173030 | 3 TRAY in 1 CASE (0121-1730-30) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-1730-10) | 3 tray | 2020-06-18 | 0000-00-00 | No | No | Current |