Head and Shoulders
- Product NDC
- 37000-078
- 11-digit product format
- 370000078
- Labeler code
- 37000
- Product ID
- 37000-078_4cda90a8-cfc7-00fd-e063-6294a90aa27d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pyrithione Zinc
- Dosage form
- LOTION/SHAMPOO
- Route
- TOPICAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M032
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-09-01
- Substance
- PYRITHIONE ZINC
- Active strength
- 1 g/100mL
- 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 | 37000-078 | 37000-078-01 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 37000-078 | 37000-078-11 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 37000-078 | 37000-078-12 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 37000-078 | 37000-078-25 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 37000-078 | 37000-078-40 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 37000-078 | 37000-078-70 | D | Discontinued by firm | 2026-08-10 |
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 | 37000-078-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-95 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-11 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-25 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 37000-078-70 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-95 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-11 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-25 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 37000-078-70 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-40 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-95 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-11 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-25 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 37000-078-70 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-40 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-95 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-11 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-25 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-12 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 37000-078-70 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-40 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-95 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-11 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-25 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-12 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 37000-078-70 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-40 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-95 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-11 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-25 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-12 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 37000-078-70 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-40 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-95 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-11 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-25 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-12 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 37000-078-70 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-40 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-95 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-11 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-25 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-12 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 37000-078-70 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 37000-078-40 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 37000-078-95 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 37000-078-11 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 37000-078-25 | 0efc9e666f02… | f202fb6c5f17… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Head and Shoulders
- Brand name suffix
- Green Apple 2in1
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PYRITHIONE ZINC | 1 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R953O2RHZ5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c036c9a6-6507-4037-b97b-1b015dd950c1 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37000-078-01 | Head and ShouldersGreen Apple 2in1 | 1000 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 1000 | 13 | |
| 37000-078-02 | Head and ShouldersGreen Apple 2in1 | 950 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 950 | 13 | |
| 37000-078-02 | Head and ShouldersGreen Apple 2in1 | 2 in 1 CELLO PACK | LOTION/SHAMPOO | 2 | 13 | |
| 37000-078-11 | Head and ShouldersGreen Apple 2in1 | 1180 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 1180 | 13 | |
| 37000-078-12 | Head and ShouldersGreen Apple 2in1 | 1280 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 1280 | 13 | |
| 37000-078-25 | Head and ShouldersGreen Apple 2in1 | 250 mL in 1 BOTTLE, PLASTIC | LOTION/SHAMPOO | 250 | 13 | |
| 37000-078-37 | Head and ShouldersGreen Apple 2in1 | 370 mL in 1 BOTTLE, PLASTIC | LOTION/SHAMPOO | 370 | 13 | |
| 37000-078-40 | Head and ShouldersGreen Apple 2in1 | 400 mL in 1 BOTTLE, PLASTIC | LOTION/SHAMPOO | 400 | 13 | |
| 37000-078-61 | Head and ShouldersGreen Apple 2in1 | 613 mL in 1 BOTTLE, PLASTIC | LOTION/SHAMPOO | 613 | 13 | |
| 37000-078-70 | Head and ShouldersGreen Apple 2in1 | 700 mL in 1 BOTTLE, PLASTIC | LOTION/SHAMPOO | 700 | 13 | |
| 37000-078-83 | Head and ShouldersGreen Apple 2in1 | 835 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 835 | 13 | |
| 37000-078-95 | Head and ShouldersGreen Apple 2in1 | 950 mL in 1 BOTTLE, PUMP | LOTION/SHAMPOO | 950 | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 37000-078 | HEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 12 | Current NDC, Legacy NDC, 12 package rows | 20241020_c036c9a6-6507-4037-b97b-1b015dd950c1.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043244 | head & shoulders 1 % Medicated Shampoo | PSN | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 209884 | zinc pyrithione 1 % Medicated Shampoo | PSN | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 1043244 | zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders] | SBD | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 209884 | zinc pyrithione 10 MG/ML Medicated Shampoo | SCD | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 1043244 | Head & Shoulders 1 % Medicated Shampoo | SY | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 1043244 | Head & Shoulders 10 MG/ML Medicated Shampoo | SY | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 209884 | zinc pyrithione 1 % Medicated Conditioner | SY | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
| 209884 | zinc pyrithione 1 % Medicated Shampoo | SY | c036c9a6-6507-4037-b97b-1b015dd950c1 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37000-078-01 | 37000007801 | 1000 mL in 1 BOTTLE, PUMP | 1000 ml | Historical | ||||
| 37000-078-02 | 37000007802 | 2 BOTTLE, PUMP in 1 CELLO PACK (37000-078-02) / 950 mL in 1 BOTTLE, PUMP | 2021-01-01 | 0000-00-00 | No | No | Current | |
| 37000-078-11 | 37000007811 | 1180 mL in 1 BOTTLE, PUMP | 1180 ml | Historical | ||||
| 37000-078-12 | 37000007812 | 1280 mL in 1 BOTTLE, PUMP (37000-078-12) | 1280 ml | 2017-01-17 | 0000-00-00 | No | No | Current |
| 37000-078-25 | 37000007825 | 250 mL in 1 BOTTLE, PLASTIC | 250 ml | Historical | ||||
| 37000-078-37 | 37000007837 | 370 mL in 1 BOTTLE, PLASTIC (37000-078-37) | 370 ml | 2022-12-01 | No | No | Current | |
| 37000-078-40 | 37000007840 | 400 mL in 1 BOTTLE, PLASTIC (37000-078-40) | 400 ml | 2013-09-13 | 0000-00-00 | No | No | Current |
| 37000-078-61 | 37000007861 | 613 mL in 1 BOTTLE, PLASTIC (37000-078-61) | 613 ml | 2022-12-01 | No | No | Current | |
| 37000-078-70 | 37000007870 | 700 mL in 1 BOTTLE, PLASTIC (37000-078-70) | 700 ml | 2013-09-13 | 0000-00-00 | No | No | Current |
| 37000-078-83 | 37000007883 | 835 mL in 1 BOTTLE, PUMP (37000-078-83) | 835 ml | 2022-12-01 | No | No | Current | |
| 37000-078-95 | 37000007895 | 950 mL in 1 BOTTLE, PUMP (37000-078-95) | 950 ml | 2016-10-01 | 0000-00-00 | No | No | Current |